Skip to content

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

CompletedPhase 3NCT00325858
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
Sponsor
Bausch Health Americas, Inc.
Start date
2002-01
Sex
All
Age range
from 18 Years to 74 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients with American College of Rheumatology (ACR) Functional Class I-III OA of the knee or hip * Patients with involvement of at least one knee or hip joint that warrants treatment with COX-2 inhibitors, NSAIDS, acetaminophen, or opioid analgesics for at least 75 of the 90 days preceding the screening visit * Patients with a pain intensity score in index joint \>=40 mm on the visual analog scale (VAS) at the baseline visit * Patients who are able to discontinue acetaminophen, NSAIDS, COX-2 selective inhibitors, and other analgesics during the washout period and throughout the study * Patients who are able to understand the study procedures and complete pain scales Exclusion Criteria: * Patients with a medical condition, other than OA, uncontrolled with treatment or any clinically significant condition that, in the investigator's opinion, precludes study participation or interferes with the assessment of chronic pain and other OA symptoms * Patients with a diagnosis of inflammatory arthritis, gout, pseudo-gout or Paget's disease, that, in the investigator's opinion, interferes with the assessment of pain and other symptoms of OA * Patients with a diagnosis of chronic pain syndrome * Patients with an ACR or a clinical diagnosis of fibromyalgia * Patients with a clinically significant form of joint disease or prior joint replacement surgery at the index joint * Patients with an anticipated need for surgery or other invasive procedure in the index joint

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00325858