Overview
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
Status:
Completed
Completed
Trial end date:
2003-12-01
2003-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bausch Health Americas, Inc.Valeant Pharmaceuticals International, Inc.
Treatments:
TramadolCriteria
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