A Phase 3 interventional study of oxycodone and placebo in Osteoarthritis, Knee and Pain, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-04-18.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).
The primary objective of this randomized (study medication assigned to patients by chance), double-blind (neither patient nor investigator knows the study medication) , phase III, placebo and active controlled trial is to evaluate the efficacy and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain from osteoarthritis (OA) of the knee. The study is being conducted for registration and approval of tapentadol (CG5503) in the US and outside the US. The trial will consist of five periods: screening (to assess eligibility) , washout (3-7 days with determination of a baseline pain intensity), titration (of dose over 3 weeks to the optimal individual level) , maintenance (investigational drug intake for 12 weeks with adjustments allowed), and follow-up (2 weeks post treatment discontinuation). The study hypothesis is that the study drug will be more effective than placebo in reducing patients pain intensity. The Secondary objectives include the collection of pharmacokinetic (related to how the body uses the drug) information for dose verification. The trial objectives will be assessed by comparing the baseline pain level to the level of week 12 of the maintenance phase. This will be done by looking at the patient's pain diary information. Titrate tapentadol (CG5503) ER (extended release) 50mg to patient's optimal dose ranging between 100mg and 250mg twice a day; Oxycodone CR (controlled release) 10mg to 50mg twice a day; Placebo (no active ingredients). All doses of trial treatment will be taken orally with approximately 120 mL of water with or without food for a maximum timeframe of 15 weeks.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 1,030 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 465 studies on the registry; none are open to participants now.
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Exclusion Criteria:
tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks
Drug: tapentadol (CG5503)
oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks
Drug: oxycodone
placebo matching placebo twice a day (BID) during 15 weeks
Drug: placebo
10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks
matching placebo twice a day (BID) during 15 weeks
50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time frame: Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).
Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12
Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability
Time frame: Baseline and 12 week endpoint
Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.
A Sleep Questionniare addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement.
Time frame: Baseline and 12 week endpoint
Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)
Time frame: Baseline and 12 week endpoint
Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint
Time frame: Baseline to 12 weeks
Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead
Time frame: Baseline and 12 week endpoint
Change From Baseline in Responder Analysis 50% Improvement to Week 12
Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time frame: Baseline and Week 12
The recruitment period for this out-patient, multicenter study occurred between 07 February 2007 and 15 July 08.
| Milestone | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Started | 344 | 342 | 337 |
| Completed | 181 | 118 | 203 |
| Not completed | 163 | 224 | 134 |
| Withdrew: Adverse event | 61 | 140 | 22 |
| Withdrew: Lost to follow-up | 5 | 0 | 3 |
| Withdrew: Withdrawal by subject | 50 | 48 | 43 |
| Withdrew: Lack of efficacy | 15 | 7 | 35 |
| Withdrew: Study drug non-compliant | 6 | 7 | 4 |
| Withdrew: All other | 26 | 21 | 27 |
| Withdrew: Death | 0 | 1 | 0 |
For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
| Scores on a scale | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. | -3.0 ± 2.39 | -2.6 ± 2.38 | -2.2 ± 2.54 |
Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability
| Scores on a scale | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | -1.2 ± 0.82 | -1.1 ± 0.87 | -0.9 ± 0.84 |
A Sleep Questionniare addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement.
| Hours | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | 0.2 ± 2.8 | 0.1 ± 1.81 | 0.3 ± 2.72 |
Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved)
| percentage of participants | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | 51.1 | 37.7 | 32.4 |
The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint
No measurements were reported for this outcome.
Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead
| scores on a scale | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12 | 0.6 ± 0.26 | 0.5 ± 0.28 | 0.5 ± 0.29 |
Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
| Percentage of participants | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Change From Baseline in Responder Analysis 50% Improvement to Week 12 | 32.0 | 17.3 | 24.3 |
Collected over All adverse events were reported from the time a signed and dated informed consent was obtained throughout the follow-up phase of the study. Serious adverse events were collected for 30 days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tapentadol (CG5503) | — | 4/344 (1.2%) | 200/344 (58.1%) |
| Oxycodone | — | 10/342 (2.9%) | 269/342 (78.7%) |
| Placebo | — | 6/337 (1.8%) | 134/337 (39.8%) |
| Event | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| Renal Failure AcuteRenal and urinary disorders | 0/344 | 2/342 | 0/337 |
| Myocardial InfarctionCardiac disorders | 0/344 | 1/342 | 1/337 |
| Pyelonephritis AcuteInfections and infestations | 0/344 | 0/342 | 1/337 |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 0/344 | 0/342 | 1/337 |
| Abdominal PainGastrointestinal disorders | 0/344 | 0/342 | 1/337 |
| Embolic StrokeNervous system disorders | 0/344 | 0/342 | 1/337 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/344 | 0/342 | 1/337 |
| Angina PectorisCardiac disorders | 0/344 | 1/342 | 0/337 |
| Atrial FlutterCardiac disorders | 0/344 | 1/342 | 0/337 |
| InfluenzaInfections and infestations | 0/344 | 1/342 | 0/337 |
| Event | Tapentadol (CG5503) | Oxycodone | Placebo |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 65/344 | 126/342 | 22/337 |
| NauseaGastrointestinal disorders | 74/344 | 125/342 | 23/337 |
| SomnolenceNervous system disorders | 37/344 | 67/342 | 14/337 |
| DizzinessNervous system disorders | 61/344 | 65/342 | 16/337 |
| VomitingGastrointestinal disorders | 18/344 | 61/342 | 11/337 |
| HeadacheNervous system disorders | 51/344 | 50/342 | 56/337 |
| PruritusSkin and subcutaneous tissue disorders | 24/344 | 43/342 | 4/337 |
| FatigueGeneral disorders | 37/344 | 35/342 | 15/337 |
| Back PainMusculoskeletal and connective tissue disorders | 7/344 | 5/342 | 22/337 |
| Dry MouthGastrointestinal disorders | 22/344 | 15/342 | 8/337 |
| Age, Categorical(Participants) | Tapentadol (CG5503) | Oxycodone | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 249 | 249 | 260 | 758 |
| >=65 years | 95 | 93 | 77 | 265 |
| Age Continuous(years) | Tapentadol (CG5503) | Oxycodone | Placebo | Total |
|---|---|---|---|---|
| Mean | 58.4 ± 10.09 | 58.2 ± 10.29 | 58.2 ± 9.15 | 58.3 ± 9.85 |
| Sex: Female, Male(Participants) | Tapentadol (CG5503) | Oxycodone | Placebo | Total |
|---|---|---|---|---|
| Female | 216 | 202 | 200 | 618 |
| Male | 128 | 140 | 137 | 405 |
No study locations are listed for this record.
The record gives a start of Jan 2007, a primary completion of Jul 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2010, 1 year 9 months after primary completion.
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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tapentadol
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