A Phase 4 interventional study of Pregabalin and Placebo in Bone Neoplasms, Pain, Intractable and Cancer, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Terminated at 55 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.
Pfizer decided to discontinue additional enrollment into the study effective Sept 5 2010 after assessing the feasibility of completing this study in a realistic timeframe.The study was not stopped for any safety concerns.
322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.
This study's enrollment of 152 is above the median of 50 across 218 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
flexible dosing
Drug: Pregabalin
Drug: Placebo
Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
Placebo
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.
Time frame: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
DAAC From Baseline in Daily Worst Pain, Days 1 Through 28
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.
Time frame: Baseline, Days 1 through 28 or ET
DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.
Time frame: Baseline, Day 1 to End of Dose Adjustment or ET
DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.
Time frame: Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4
m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.
Time frame: Baseline, Week 4 or ET
Change From Baseline in mBPI-sf Interference Index Score at Week 4
m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.
Time frame: Baseline, Week 4 or ET
Change From Baseline in Average Pain Scores at Weeks 1, 2, 3 and 4
Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.
Time frame: Baseline, Weeks 1, 2, 3 and 4 or ET
Change From Baseline in Total Daily Dose of Opioids Day 0 Through Day 28
Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.
Time frame: Baseline, Day 0 through Day 28 or ET
Change From Pre-Baseline in Total Daily Dose of Morphine Equivalents Day 0 Through Day 28
IR and SR formulations separately and combined. Change was day x minus baseline.
Time frame: Baseline, Day 0 through Day 28 or ET
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 4
HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.
Time frame: Baseline, Week 4 or ET
Patient Global Impression of Change (PGIC)
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
Time frame: Weeks 2 and 4 or ET
Change From Baseline in Opioid-Related Symptoms Distress Scale (OR-SDS) at Day 14 and Day 28
OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.
Time frame: Baseline, Day 14, Day 28 or ET
Change From Baseline in Eastern Cooperative Oncology Group Performance (ECOG) Status Scale at Day 28
ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.
Time frame: Baseline, Day 28 or ET
A0081128 terminated on 01-SEP-2010 due to slow enrollment, analysis at 50 percent (%) enrollment determined that increasing the sample size would require significant extension of enrollment period.
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 72 | 80 |
| Completed | 59 | 59 |
| Not completed | 13 | 21 |
| Withdrew: Death | 3 | 4 |
| Withdrew: Lack of efficacy | 2 | 4 |
| Withdrew: Other | 2 | 2 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Adverse event | 2 | 7 |
DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=72, 79) | 6.28 ± 1.68 | 6.47 ± 1.59 |
| Change at Day 28 (n=72, 77) | -1.53 ± 1.81 | -1.23 ± 1.74 |
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| DAAC From Baseline in Daily Worst Pain, Days 1 Through 28 | -1.27 ± 1.45 | -1.03 ± 1.37 |
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment | -0.72 ± 1.11 | -0.53 ± 1.01 |
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28 | -1.47 ± 1.79 | -1.15 ± 1.72 |
m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=71, 77) | 5.18 ± 1.80 | 5.03 ± 1.72 |
| Change at Week 4 (n=59, 59) | -2.06 ± 1.75 | -1.41 ± 2.51 |
| Change at Week 4/LOCF (n=64, 63) | -1.94 ± 1.88 | -1.35 ± 2.54 |
m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| Baseline (n=71, 76) | 4.92 ± 2.22 | 5.27 ± 2.14 |
| Change at Week 4 (n=59, 58) | -1.83 ± 2.47 | -1.50 ± 2.44 |
| Change at Week 4/LOCF(n=64, 62) | -1.66 ± 2.57 | -1.48 ± 2.56 |
Change from baseline in daily average pain score NRS 0 (no pain) to 10 (pain as bad as you can imagine) for pain intensity over past 24 hours recorded every evening before bedtime. Change was week x average minus baseline average.
No measurements were reported for this outcome.
Change from baseline in total daily dose of opioids immediate release (IR), sustained release (SR) formulations separately and combined.
No measurements were reported for this outcome.
IR and SR formulations separately and combined. Change was day x minus baseline.
No measurements were reported for this outcome.
HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline.
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| Anxiety Baseline (n= 72, 78) | 11.61 ± 2.94 | 11.60 ± 2.74 |
| Anxiety Change at Week 4 (n= 60, 60) | 0.98 ± 3.31 | 0.80 ± 2.29 |
| Anxiety Change at Week 4/LOCF (n=64, 65) | 0.80 ± 3.37 | 0.71 ± 2.42 |
| Depression Baseline (n= 72, 78) | 9.33 ± 2.18 | 10.15 ± 2.59 |
| Depression Change at Week 4 (n= 60, 60) | 0.20 ± 2.77 | -0.57 ± 2.13 |
| Depression Change at Week 4/LOCF (n=64, 65) | 0.22 ± 2.73 | -0.57 ± 2.81 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
| Units on a scale | Pregabalin | Placebo |
|---|---|---|
| Week 2 (n=66,68) | 2.97 ± 1.36 | 3.09 ± 1.19 |
| Week 4 (n=59, 60) | 2.73 ± 1.39 | 2.87 ± 1.46 |
| LOCF/ET (n=69, 74) | 2.88 ± 1.46 | 2.99 ± 1.45 |
OR-SDS included OR-SDS individual items by dimension of frequency (rarely to almost constantly), severity (slight to very severe), and degree of bother (not at all to very much), number of episodes of retching/vomiting, OR-SDS dimension composite and overall composite scores. Change was scores at occurance minus score at baseline.
No measurements were reported for this outcome.
ECOG - assessed disease progression and how disease affected the daily living abilities of the participant and determined appropriate treatment and prognosis. Graded 0 (fully active able to carry on all pre-disease performance without restrictions) to 5 (dead). Change was day 28 minus baseline.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 12/72 (16.7%) | 38/72 (52.8%) |
| Placebo | — | 12/80 (15%) | 31/80 (38.8%) |
| Event | Pregabalin | Placebo |
|---|---|---|
| Disease progressionGeneral disorders | 4/72 | 3/80 |
| AnaemiaBlood and lymphatic system disorders | 2/72 | 1/80 |
| PneumoniaInfections and infestations | 2/72 | 1/80 |
| Neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/72 | 0/80 |
| Device dislocationGeneral disorders | 1/72 | 0/80 |
| Lower respiratory tract infectionInfections and infestations | 1/72 | 0/80 |
| TonsillitisInfections and infestations | 1/72 | 0/80 |
| Back painMusculoskeletal and connective tissue disorders | 1/72 | 0/80 |
| Cerebral infarctionNervous system disorders | 1/72 | 0/80 |
| Renal failure acuteRenal and urinary disorders | 1/72 | 0/80 |
| Event | Pregabalin | Placebo |
|---|---|---|
| SomnolenceNervous system disorders | 18/72 | 6/80 |
| DizzinessNervous system disorders | 11/72 | 7/80 |
| NauseaGastrointestinal disorders | 7/72 | 10/80 |
| FatigueGeneral disorders | 8/72 | 4/80 |
| VomitingGastrointestinal disorders | 6/72 | 4/80 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 6/72 | 2/80 |
| DiarrhoeaGastrointestinal disorders | 5/72 | 3/80 |
| TremorNervous system disorders | 5/72 | 2/80 |
| VertigoEar and labyrinth disorders | 4/72 | 0/80 |
| Oedema peripheralGeneral disorders | 4/72 | 3/80 |
| Age, Categorical(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 54 | 104 |
| >=65 years | 22 | 26 | 48 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 36 | 41 | 77 |
| Male | 36 | 39 | 75 |
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.