Phase 3
Completed N=238
A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol OAD Tablets to Twice Daily Tramadol BID for the Treatment of Osteoarthritis of the Knee (Extension Protocol) and Open Label Safety Follow-Up
Postoperative Pain · Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT00912015 ↗
Enrolled (actual)
238
Serious AEs
2.5%
Results posted
Jun 2009
Primary outcomePrimary: Adverse Events: 12-months Safety Population — 14; 9; 1; 9 participants
Summary
The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events: 12-months Safety Population |
14; 9; 1; 9; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female patients between the ages of 40-75 with a diagnosis of Osteoarthritis of the knee consistent with the ACR Clinical Classification Criteria for Arthritis of the Knee (Altman, R. et al., 1991):
- 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 one 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, would adversely affect the patient's ability to complete the study or its measures.
Data sourced from ClinicalTrials.gov (NCT00912015). 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.