Phase 3
Completed N=1,028
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis
Source: ClinicalTrials.gov NCT00833794 ↗Enrolled (actual)
1,028
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation) — 4.3; 4.8 Points on a scale
Summary
The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation) |
4.3; 4.8 | — |
| SECONDARY Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment |
4.0; 4.5 | — |
| SECONDARY Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation) |
4.3; 4.8; 4.1; 4.4 | — |
| SECONDARY WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation) |
6.9; 7.5 | — |
| SECONDARY WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation) |
24.9; 27.5 | — |
| SECONDARY Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation) |
86; 27; 148; 59; 108; 58 | — |
| SECONDARY Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation) |
76; 25; 154; 71; 108; 49 | — |
| SECONDARY Time to Response |
14; 14; 14; 15; 16; 39 | — |
| SECONDARY Discontinuation Due to Lack of Efficacy |
34; 22 | — |
| SECONDARY Discontinuation Due to Adverse Events |
44; 12 | — |
Eligibility Criteria
Inclusion Criteria for Open-Label phase:
- Males or females
- Must be between the ages of 40-80
- Must meet the American College of Rheumatology (ACR) Clinical Classification Criteria for Osteoarthritis of the Knee:
- Current knee pain
- Less than 30 minutes of morning stiffness with or without crepitus on active motion
- Confirmation either by arthroscopy or radiologist's report (X-rays showing osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation}) within five years prior to entry into the study
- Must have a history of exposure to treatment (for pain due to osteoarthritis (OA) of the knee) with Non-steroidal anti-inflammatory drugs (NSAIDs), COX II inhibitors or tramadol.
- Must be taking one of the above medications on a regular basis in the 30 days prior to Visit 2 (S0).
- Must meet the following criteria for severity of pain at Visit 2 (Day S0):
- Have a score of ≥ 4 on the 11-point Numerical Rating Scale (PI-NRS; range: 0-10)
- Have a total increase of ≥ 2 points on the 11-point Numerical Rating Scale (range: 0-10) compared to the rating at Visit 1 (Day SX)
- Must have a erythrocyte sedimentation rate (ESR) 3 times the upper boundary of the normal range
- Has significant renal disease (defined as creatinine clearance <30 mL/min
- Has a history of current or past substance abuse or dependence, other than nicotine
- Has a known and documented allergy to tramadol or any structurally similar drugs (e.g. opiates)
- Has a known and documented allergy to acetaminophen or any structurally similar drugs
- Has any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures.
Inclusion criteria for the double-blinded phase:
- Patients must continue to meet the open-label eligibility criteria and
- Must have a score of ≥ 4 on the Numerical Rating Scale (NRS) with a total increase of ≥ 2 points on the NRS compared to Visit 3(Day R14) and
- Must not have taken any of the prohibited medications during the Open-label Phase.
Exclusion criteria for the double-blinded phase:
- Patient Request
- Adverse Events that contraindicate further administration of the study medication
- Any other situation where in the opinion of the Investigator continued participation in the study would not be in the patient's best interest.
Data sourced from ClinicalTrials.gov (NCT00833794). 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.