Phase 3
Completed N=990
A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Source: ClinicalTrials.gov NCT00486811 ↗Enrolled (actual)
990
Serious AEs
1.9%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). — -2.2; -2.5; -2.1 Units on a scale
Summary
The purpose of this study is to evaluate whether tapentadol (CG5503) prolonged-release (PR) tablets at doses of 100-250 mg twice daily provide a better pain relief in patients with moderate to severe chronic pain due to osteoarthritis of the knee than a placebo (a medication without active substance). In addition the tolerability of CG5503 PR will be assessed. One third of the patients will receive CG5503 and one third will receive placebo. For further comparison one third of the patients will receive oxycodone controlled release (CR) at doses of 20-50 mg twice daily which is an active approved pain medication. Please note that tapentadol ER (Extended Release) and tapentadol PR (Prolonged Release) are identical and used interchangeably. This is due to United States of America and European naming conventions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS). |
-2.2; -2.5; -2.1 | — |
| SECONDARY 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. |
-2.5; -2.7; -2.3 | — |
| SECONDARY Patient Global Impression of Change |
33; 40; 25; 94; 99; 65 | — |
| SECONDARY Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 |
-1.0; -1.0; -1.1 | — |
| SECONDARY Time to Treatment Discontinuation Due to Lack of Efficacy |
— | — |
| SECONDARY Change in the Health Survey Scores Form (SF-36) |
11.1; 11.70; 9.5; 18.7; 20.8; 13.8 | — |
| SECONDARY EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time |
0.2; 0.2; 0.1 | — |
| SECONDARY Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period. |
0.4; 0.2; 0.2 | — |
| SECONDARY Sleep Questionnaire: Amount of Time Slept in Hours |
0.2; 0.2; 0.3 | — |
| SECONDARY Sleep Questionnaire: Number of Awakenings During Sleep |
32; 33; 29; 55; 44; 46 | — |
| SECONDARY Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire) |
11; 8; 5; 10; 15; 19 | — |
| SECONDARY Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time |
-0.1; 0.1; 0.3; 0.0; 0.1; 0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I- III;
- Patients taking analgesic medications for at least 3 months prior to screening and dissatisfied with their current therapy;
- Patients requiring opioid treatment must be taking daily doses of opioid- based analgesic, equivalent to =5 on an 11-point numeric rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.
Exclusion Criteria
- History of alcohol and/or drug abuse in Investigator's judgment;
- Chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months;
- Life-long history of seizure disorder or epilepsy;
- History of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated;
- Uncontrolled hypertension;
- Patients with severely impaired renal function;
- Patients with moderate to severely impaired hepatic function or with laboratory values reflecting inadequate hepatic function,
- Treatment with neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, anticonvulsants, or anti-parkinsonian drugs, treatment with any other analgesic therapy than investigational medication or rescue medication during the trial.
Data sourced from ClinicalTrials.gov (NCT00486811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.