Phase 3
Completed N=431
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee
Osteoarthritis, Knee · Postoperative Pain
Source: ClinicalTrials.gov NCT00950651 ↗
Enrolled (actual)
431
Serious AEs
2.6%
Results posted
Aug 2009
Primary outcomePrimary: Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 — 58.3; 58.7 percentage of change
Summary
A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 |
58.3; 58.7 | — |
| SECONDARY Arthritis Pain at the End of Dosing Interval (24-hour Efficacy) |
20; 19; 42; 33; 35; 40 | — |
| SECONDARY Percentage of Change From Baseline in WOMAC Stiffness Subscale Score at Week 12 |
49.1; 49.5 | — |
| SECONDARY Percentage of Change From Baseline in WOMAC Physical Function Subscale Score at Week 12 |
50.8; 49.8 | — |
| SECONDARY Percentage of Change From Baseline in WOMAC Total Score at Week 12 |
52.9; 52.0 | — |
| SECONDARY Percentage of Change From Baseline in Current Pain at Week 12 |
35.1; 34.6 | — |
| SECONDARY Percentage of Change From Baseline in Least Pain Within Last 24 Hours at Week 12 |
21.6; 23.5 | — |
| SECONDARY Percentage of Change From Baseline in Worst Pain Within Last 24 Hours at Week 12 |
38.6; 39.2 | — |
| SECONDARY Percentage of Change From Baseline in Average Pain Within Last 24 Hours at Week 12 |
30.1; 30.7 | — |
| SECONDARY Percentage of Change From Baseline in Walking Time for 15 Meters at Week 12 |
5.639; 4.738 | — |
| SECONDARY Patient Global Rating of Pain Relief at Week 12 |
160; 151; 1; 2 | — |
| SECONDARY Patient Global Assessment: Side Effects Interfering With Day to Day Activities at Week 12 |
7; 2; 15; 18; 39; 34 | — |
| SECONDARY Patient Global Assessment: Current Pain Relief Versus Pain Relief During Previous Tramadol Treatment at Week 12 |
0; 0; 4; 2; 11; 3 | — |
| SECONDARY Patient Global Assessment: Current Interfering Side Effects Versus Pain Relief During Previous Tramadol Treatment at Week 12 |
4; 8; 2; 1; 13; 4 | — |
| SECONDARY Physician Overall Rating: Overall Assessment at Week 12 |
160; 150; 1; 3 | — |
| SECONDARY Physician Overall Rating: Effectiveness of Pain Control 24 Hours After the Most Recent Dose of Tramadol at Week 12 |
160; 151; 1; 2 | — |
| SECONDARY Patient Diary: Pain (Between Visit Means) at Week 12 |
2.74; 2.86 | — |
| SECONDARY Patient Diary: Stiffness (Between Visit Means) at Week 12 |
2.67; 2.82 | — |
| SECONDARY Patient Diary: Ability Getting Things Done (Between Visit Means) at Week 12 |
2.41; 2.34 | — |
| SECONDARY Patient Diary: Difficulty With Walking (Between Visit Means) at Week 12 |
2.79; 2.85 | — |
| SECONDARY Patient Diary: Difficulty With Stairs (Between Visit Means) at Week 12 |
2.97; 3.10 | — |
Eligibility Criteria
Inclusion Criteria
- Males or Females between the ages of 40 and 75 with a diagnosis of Osteoarthritis (OA) of the knee consistent with the American College of Rheumatology (ACR) Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1986):
- Knee pain at study enrolment,
- 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 1 year prior to entry into the study.
- ESR 3 times the upper boundary of the normal range.
- Patients with significant renal disease, defined as creatinine clearance <30 mL/min as estimated by the method of Levey et al., 1999.
- Current substance abuse or dependence, other than nicotine.
- Allergy or adverse reaction to tramadol or any structurally similar drugs e.g. opiates.
- Any other condition that, in the opinion of the investigators, adversely affected the patient's ability to complete the study or its measures.
Data sourced from ClinicalTrials.gov (NCT00950651). 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.