A Phase 2 interventional study of Anti-NGF AB in Neoplasms and Bone Metastases, sponsored by Pfizer. Completed at 23 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 41 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
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Exclusion Criteria:
Biological: Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks
Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029) and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time frame: Baseline of Study A4091003, Baseline (A4091029), and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
Time frame: Baseline and Weeks 4, 8, 16, 24, 40, 48, 56 and 64 of Study A4091029
| Milestone | Tanezumab 10 mg (A4091029) |
|---|---|
| Started | 41 |
| Received tanezumab in parent study a4091003 | 19 |
| Received placebo in parent study a4091003 | 22 |
| Completed | 15 |
| Not completed | 26 |
| Withdrew: Adverse event | 6 |
| Withdrew: Death | 11 |
| Withdrew: Insufficient clinical response | 1 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Progressive disease | 2 |
| Withdrew: Other - unspecified | 1 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) |
|---|---|---|
| Baseline (A4091029) | -1.00 ± 2.16 | -1.17 ± 1.72 |
| Week 4 | -1.67 ± 2.17 | -1.88 ± 1.76 |
| Week 8 | -1.33 ± 1.50 | -1.87 ± 1.55 |
| Week 16 | -1.58 ± 2.02 | -2.15 ± 2.41 |
| Week 24 | -1.60 ± 1.58 | -2.58 ± 1.68 |
| Week 40 | 0.50 ± 1.38 | -2.44 ± 2.65 |
| Week 48 | — | -1.00 |
| Week 56 | — | -1.00 |
| Week 64 | — | -4.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the average pain score, minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Tanezumab 10 mg (A4091029) |
|---|---|
| Week 4 (n=33) | -0.82 ± 1.55 |
| Week 8 (n=29) | -0.69 ± 1.28 |
| Week 16 (n=24) | -0.67 ± 2.14 |
| Week 24 (n=21) | -1.19 ± 1.75 |
| Week 40 (n=14) | -0.21 ± 2.86 |
| Week 48 (n=1) | 0.00 |
| Week 56 (n=1) | 0.00 |
| Week 64 (n=1) | -3.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) |
|---|---|---|
| Baseline (A4091029) | -0.68 ± 2.69 | -0.72 ± 2.08 |
| Week 4 | -1.22 ± 2.44 | -1.24 ± 1.71 |
| Week 8 | -0.87 ± 2.17 | -0.87 ± 1.92 |
| Week 16 | -0.67 ± 2.96 | -1.23 ± 2.68 |
| Week 24 | -1.20 ± 2.10 | -2.17 ± 1.99 |
| Week 40 | -0.33 ± 2.07 | -2.11 ± 2.62 |
| Week 48 | — | -2.0 |
| Week 56 | — | -2.0 |
| Week 64 | — | -5.0 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the worst pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Tanezumab 10 mg (A4091029) |
|---|---|
| Week 4 | -0.82 ± 1.83 |
| Week 8 | -0.48 ± 1.72 |
| Week 16 | -0.25 ± 2.92 |
| Week 24 | -1.14 ± 2.20 |
| Week 40 | -0.36 ± 2.87 |
| Week 48 | 0.00 |
| Week 56 | 0.00 |
| Week 64 | -3.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) |
|---|---|---|
| Baseline (A4091029) | -1.05 ± 2.04 | -1.28 ± 2.14 |
| Week 4 | -2.28 ± 1.96 | -2.18 ± 2.07 |
| Week 8 | -1.40 ± 1.76 | -2.60 ± 1.64 |
| Week 16 | -1.67 ± 2.53 | -3.31 ± 2.32 |
| Week 24 | -2.50 ± 1.84 | -3.25 ± 1.82 |
| Week 40 | -1.00 ± 1.67 | -2.67 ± 2.83 |
| Week 48 | — | -3.0 |
| Week 56 | — | -3.0 |
| Week 64 | — | -3.0 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the least pain score (within the last 24 hours at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Tanezumab 10 mg (A4091029) |
|---|---|
| Week 4 | -1.15 ± 1.46 |
| Week 8 | -1.00 ± 1.36 |
| Week 16 | -1.08 ± 1.93 |
| Week 24 | -1.81 ± 1.60 |
| Week 40 | -1.00 ± 2.11 |
| Week 48 | -1.00 |
| Week 56 | -1.00 |
| Week 64 | -1.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) |
|---|---|---|
| Baseline (A4091029) | -0.68 ± 2.73 | -1.61 ± 1.85 |
| Week 4 | -1.67 ± 1.94 | -2.24 ± 2.31 |
| Week 8 | -1.20 ± 1.82 | -2.40 ± 2.16 |
| Week 16 | -1.08 ± 2.64 | -2.54 ± 3.04 |
| Week 24 | -1.20 ± 1.48 | -2.75 ± 2.56 |
| Week 40 | 0.00 ± 1.10 | -2.11 ± 3.76 |
| Week 48 | — | -2.00 |
| Week 56 | — | -4.00 |
| Week 64 | — | -4.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Questions 1 to 4 measure the magnitude of pain at its worst, least, average, and 'right now'. Responses are provided by the participant on an 11 point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Measure can be scored by item, with lower scores being indicative of less pain. Negative Score indicates decrease in pain and Positive Score indicates increase in pain. This measure denotes the right now pain score (at the time of the questionnaire), minimum score = 0 and maximum score = 10 with lower scores indicative of less pain.
| units on a scale | Tanezumab 10 mg (A4091029) |
|---|---|
| Week 4 | -0.82 ± 1.61 |
| Week 8 | -0.72 ± 1.62 |
| Week 16 | -0.67 ± 2.62 |
| Week 24 | -0.95 ± 1.72 |
| Week 40 | -0.21 ± 3.49 |
| Week 48 | -1.00 |
| Week 56 | -3.00 |
| Week 64 | -3.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
| units on a scale | Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) |
|---|---|---|
| Baseline (A4091029) | -0.81 ± 2.32 | -1.10 ± 2.11 |
| Week 4 | -2.03 ± 2.02 | -1.26 ± 1.91 |
| Week 8 | -1.22 ± 1.49 | -1.61 ± 2.13 |
| Week 16 | -1.05 ± 2.35 | -1.38 ± 2.56 |
| Week 24 | -1.41 ± 1.84 | -1.94 ± 1.87 |
| Week 40 | -0.90 ± 2.04 | -2.38 ± 2.89 |
| Week 48 | — | -3.00 |
| Week 56 | — | -3.29 |
| Week 64 | — | -5.43 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference. The BPI-sf Pain Interference with Function Composite score is calculated as the average of the seven item subsets (questions 5A to G) in the BPI-sf questionnaire. If one of the seven items was missing then the average score of the remaining items was used to impute the missing (seventh) value. If more than one item was missing then the composite score was missing.
| units on a scale | Tanezumab 10 mg (A4091029) |
|---|---|
| Week 4 | -0.69 ± 1.33 |
| Week 8 | -0.79 ± 1.90 |
| Week 16 | -0.29 ± 2.46 |
| Week 24 | -0.88 ± 1.77 |
| Week 40 | -0.56 ± 2.81 |
| Week 48 | -1.71 |
| Week 56 | -2.00 |
| Week 64 | -4.14 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with, general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
| units on a scale | Placebo (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) | Tanezumab 10 mg (A4091003 [NCT00545129]) to Tanezumab 10 mg (A4091029) |
|---|---|---|
| General activity: Baseline | -0.68 ± 2.65 | -1.39 ± 2.57 |
| General activity: Week 4 | -1.94 ± 2.04 | -1.76 ± 2.11 |
| General activity: Week 8 | -1.47 ± 2.17 | -2.27 ± 2.19 |
| General activity: Week 16 | -1.00 ± 2.95 | -1.31 ± 3.09 |
| General activity: Week 24 | -1.60 ± 1.71 | -2.17 ± 2.37 |
| General activity: Week 40 | -0.83 ± 1.72 | -2.78 ± 3.03 |
| General activity: Week 48 | — | -3.00 |
| General activity: Week 56 | — | -3.00 |
| General activity: Week 64 | — | -6.00 |
| Mood: Baseline | -1.58 ± 1.98 | -0.94 ± 2.78 |
| Mood: Week 4 | -2.33 ± 1.78 | -1.53 ± 2.48 |
| Mood: Week 8 | -2.27 ± 2.43 | -1.53 ± 2.72 |
| Mood: Week 16 | -1.50 ± 2.97 | -1.62 ± 3.57 |
| Mood: Week 24 | -2.20 ± 2.90 | -1.58 ± 2.87 |
| Mood: Week 40 | -1.00 ± 2.97 | -2.56 ± 3.05 |
| Mood: Week 48 | — | -4.00 |
| Mood: Week 56 | — | -4.00 |
| Mood: Week 64 | — | -7.00 |
| Walking ability: Baseline | -0.67 ± 2.77 | -0.17 ± 2.57 |
| Walking ability: Week 4 | -1.65 ± 2.57 | -0.24 ± 2.25 |
| Walking ability: Week 8 | -0.86 ± 2.25 | -0.73 ± 1.83 |
| Walking ability: Week 16 | -1.00 ± 2.93 | -0.23 ± 1.88 |
| Walking ability: Week 24 | -1.00 ± 2.75 | -0.92 ± 1.88 |
| Walking ability: Week 40 | -1.50 ± 2.81 | -0.63 ± 3.07 |
| Walking ability: Week 48 | — | -3.00 |
| Walking ability: Week 56 | — | -4.00 |
| Walking ability: Week 64 | — | -5.00 |
| Normal work: Baseline | -0.28 ± 2.85 | -1.28 ± 2.61 |
| Normal work: Week 4 | -1.41 ± 3.43 | -1.12 ± 2.74 |
| Normal work: Week 8 | -0.50 ± 2.71 | -1.93 ± 2.94 |
| Normal work: Week 16 | -1.00 ± 2.28 | -1.00 ± 3.29 |
| Normal work: Week 24 | -1.10 ± 2.33 | -1.75 ± 2.83 |
| Normal work: Week 40 | -0.67 ± 2.88 | -1.88 ± 4.49 |
| Normal work: Week 48 | — | 1.00 |
| Normal work: Week 56 | — | 0.00 |
| Normal work: Week 64 | — | -3.00 |
| Relations with other people: Baseline | -0.50 ± 2.92 | -1.28 ± 2.44 |
| Relations with other people: Week 4 | -2.41 ± 2.50 | -1.41 ± 2.29 |
| Relations with other people: Week 8 | -1.00 ± 2.04 | -1.47 ± 2.64 |
| Relations with other people: Week 16 | -1.36 ± 3.20 | -1.31 ± 2.50 |
| Relations with other people: Week 24 | -1.40 ± 2.99 | -1.92 ± 2.31 |
| Relations with other people: Week 40 | -1.17 ± 2.23 | -1.89 ± 3.06 |
| Relations with other people: Week 48 | — | -3.00 |
| Relations with other people: Week 56 | — | -3.00 |
| Relations with other people: Week 64 | — | -5.00 |
| Sleep: Baseline | -1.00 ± 2.89 | -1.00 ± 2.43 |
| Sleep: Week 4 | -2.18 ± 2.32 | -1.59 ± 2.53 |
| Sleep: Week 8 | -1.21 ± 2.01 | -1.47 ± 3.16 |
| Sleep: Week 16 | -1.09 ± 1.81 | -1.85 ± 3.02 |
| Sleep: Week 24 | -0.60 ± 1.90 | -2.08 ± 2.75 |
| Sleep: Week 40 | -0.17 ± 1.83 | -3.11 ± 3.18 |
| Sleep: Week 48 | — | -5.00 |
| Sleep: Week 56 | — | -5.00 |
| Sleep: Week 64 | — | -5.00 |
| Enjoyment of life: Baseline | -1.39 ± 2.99 | -1.67 ± 2.72 |
| Enjoyment of life: Week 4 | -2.53 ± 2.92 | -1.18 ± 2.77 |
| Enjoyment of life: Week 8 | -1.71 ± 2.64 | -1.87 ± 3.38 |
| Enjoyment of life: Week 16 | -1.09 ± 2.43 | -2.38 ± 3.50 |
| Enjoyment of life: Week 24 | -2.00 ± 2.36 | -3.17 ± 2.12 |
| Enjoyment of life: Week 40 | -1.00 ± 3.58 | -3.38 ± 3.46 |
| Enjoyment of life: Week 48 | — | -4.00 |
| Enjoyment of life: Week 56 | — | -4.00 |
| Enjoyment of life: Week 64 | — | -7.00 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. It consists of 5 questions. Question 5 consists of seven item subsets, A to G, that measure the level of interference of pain on daily functions. Items are defined as interference with: general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life mood. Responses are given on an 11 point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). Measure can be scored by item, with lower scores being indicative of less pain interference.
| units on a scale | Tanezumab 10 mg (A4091029) |
|---|---|
| General activity: Week 4 | -0.85 ± 1.84 |
| General activity: Week 8 | -1.10 ± 2.27 |
| General activity: Week 16 | 0.04 ± 2.90 |
| General activity: Week 24 | -0.90 ± 2.32 |
| General activity: Week 40 | -0.57 ± 2.93 |
| General activity: Week 48 | -1.00 |
| General activity: Week 56 | -1.00 |
| General activity: Week 64 | -4.00 |
| Mood: Week 4 | -0.70 ± 1.55 |
| Mood: Week 8 | -0.86 ± 2.26 |
| Mood: Week 16 | -0.21 ± 2.77 |
| Mood: Week 24 | -0.62 ± 1.88 |
| Mood: Week 40 | -0.14 ± 3.13 |
| Mood: Week 48 | -2.00 |
| Mood: Week 56 | -2.00 |
| Mood: Week 64 | -5.00 |
| Walking ability: Week 4 ( | -0.61 ± 1.60 |
| Walking ability: Week 8 | -0.79 ± 1.90 |
| Walking ability: Week 16 | -0.50 ± 2.11 |
| Walking ability: Week 24 | -1.05 ± 2.06 |
| Walking ability: Week 40 | -1.08 ± 2.90 |
| Walking ability: Week 48 | -2.00 |
| Walking ability: Week 56 | -3.00 |
| Walking ability: Week 64 | -4.00 |
| Normal work: Week 4 | -0.42 ± 2.02 |
| Normal work: Week 8 | -0.62 ± 2.41 |
| Normal work: Week 16 | 0.08 ± 2.78 |
| Normal work: Week 24 | -0.76 ± 1.87 |
| Normal work: Week 40 | -0.46 ± 3.36 |
| Normal work: Week 48 | -1.00 |
| Normal work: Week 56 | -2.00 |
| Normal Work: Week 64 | -5.00 |
| Relations with other people: Week 4 | -1.18 ± 2.05 |
| Relations with other people: Week 8 | -0.86 ± 2.43 |
| Relations with other people: Week 16 | -0.67 ± 2.46 |
| Relations with other people: Week 24 | -1.19 ± 2.09 |
| Relations with other people: Week 40 | -0.71 ± 2.70 |
| Relations with other people: Week 48 | -3.00 |
| Relations with other people: Week 56 | -3.00 |
| Relations with other people: Week 64 | -5.00 |
| Sleep: Week 4 | -0.94 ± 1.60 |
| Sleep: Week 8 | -0.76 ± 2.15 |
| Sleep: Week 16 | -0.63 ± 2.73 |
| Sleep: Week 24 | -0.86 ± 2.20 |
| Sleep: Week 40 | -0.71 ± 2.76 |
| Sleep: Week 48 | -1.00 |
| Sleep: Week 56 | -1.00 |
| Sleep: Week 64 | -1.00 |
| Enjoyment of life: Week 4 | -0.12 ± 1.75 |
| Enjoyment of life: Week 8 | -0.55 ± 2.57 |
| Enjoyment of life: Week 16 | -0.17 ± 3.12 |
| Enjoyment of life: Week 24 | -0.81 ± 2.40 |
| Enjoyment of life: Week 40 | -0.08 ± 3.75 |
| Enjoyment of life: Week 48 | -2.00 |
| Enjoyment of life: Week 56 | -2.00 |
| Enjoyment of life: Week 64 | -5.00 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tanezumab 10 mg (A4091029) | — | 23/41 (56.1%) | 18/41 (43.9%) |
| Event | Tanezumab 10 mg (A4091029) |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 4/41 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/41 |
| Disease progressionGeneral disorders | 3/41 |
| Pathological fractureMusculoskeletal and connective tissue disorders | 2/41 |
| Metastatic neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/41 |
| Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/41 |
| Aplastic anaemiaBlood and lymphatic system disorders | 1/41 |
| Disseminated intravascular coagulationBlood and lymphatic system disorders | 1/41 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/41 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 1/41 |
| Event | Tanezumab 10 mg (A4091029) |
|---|---|
| NauseaGastrointestinal disorders | 8/41 |
| AstheniaGeneral disorders | 6/41 |
| Oedema peripheralGeneral disorders | 5/41 |
| PyrexiaGeneral disorders | 5/41 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/41 |
| VomitingGastrointestinal disorders | 4/41 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/41 |
| ConstipationGastrointestinal disorders | 3/41 |
| Weight decreasedInvestigations | 3/41 |
| Decreased appetiteMetabolism and nutrition disorders | 3/41 |
The intent to treat (ITT) analysis set included all participants who received at least 1 of IV study medication during study.
| Age, Continuous(Years) | Tanezumab 10 mg (A4091029) |
|---|---|
| Mean | 58.7 ± 12.4 |
| Sex: Female, Male(Participants) | Tanezumab 10 mg (A4091029) |
|---|---|
| Female | 21 |
| Male | 20 |
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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