Phase 3
Completed N=1,023
Tapentadol (CG5503)
Osteoarthritis, Knee · Postoperative Pain
Source: ClinicalTrials.gov NCT00421928 ↗
Enrolled (actual)
1,023
Serious AEs
2.0%
Results posted
Apr 2010
Primary outcomePrimary: 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; -2.6; -2.2 Scores on a scale — p=<0.05
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -2.6; -2.2 | <0.05 sig |
| SECONDARY 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; -1.1; -0.9 | — |
| SECONDARY Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. |
0.2; 0.1; 0.3 | — |
| SECONDARY 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 | — |
| SECONDARY Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy |
— | — |
| SECONDARY Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12 |
0.6; 0.5; 0.5 | — |
| SECONDARY Change From Baseline in Responder Analysis 50% Improvement to Week 12 |
32.0; 17.3; 24.3 | — |
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/or dissatisfied with their current therapy
- Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to <160 mg of oral morphine
- baseline score of greater than or equal to 5 on an 11-point numerical 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 judgement
- history of significant liver insufficiency
- 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 severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function
Data sourced from ClinicalTrials.gov (NCT00421928). 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.