A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip

Chronic Pain Clinical Trial

Official title: Double-Blind, Randomized,Dose-Ranging, Parallel-Group Comparison Of The Efficacy And Safety Of Extended-Release Tramadol Hydrochloride(Tramadol HCl ER)100 Mg, 200 Mg, 300 Mg, And 400 Mg With Placebo In The Treatment Of Osteoarthritis Of Knee And/Or Hip

Status Completed

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA.

Clinical Trial Description

Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short elimination half-life of tramadol IR necessitates every 4-6 hour dosing to maintain optimal levels of analgesia in chronic pain. The study medication in this study is a once-daily, extended-release tramadol formulation. This is a 12-week multi-center, double-blind, randomized, dose-ranging, parallel-group, fixed-dose, placebo-controlled study. Patients with OA Functional Class I-III of the knee or hip (index joint) are eligible for participation, if appropriate criteria are met. During a 2-7 day washout period, the use of all analgesic medications will be discontinued. Eligible patients experiencing moderate to severe pain (<=40 mm on a 100 mm visual analog scale) in the index joint to be evaluated and who meet all other study criteria will enter in a 2-week,double-blind titration period. During this period, patients will be randomly assigned to receive treatment with tramadol HCl ER 100 mg, 200 mg, 300 mg, 400 mg or placebo, once a day. Patients will be titrated to their assigned dose between study days 1 - 15 and will continue at that dose for the remainder of the study (Week 12). Efficacy and safety evaluations will be collected at study visits occurring at Weeks 1, 2, 3, 6, 9 and 12 or at early termination. Study medication will be discontinued at Week 12 and patients will return after 1 week for a post-treatment visit (Week 13). Patients with unmanageable pain or with unacceptable side effects will be discontinued from the study and alternate analgesic therapy initiated, as appropriate. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

• NCT number: NCT00325858
• Study type: Interventional
• Source: Valeant Pharmaceuticals International, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Completion date: December 2003