An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to another medication) in Filipino participants with chronic (lasting a long time) osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutica
• Treatments: Acetaminophen; Celecoxib; Tramadol

Criteria

Inclusion Criteria:

• Diagnosed with chronic osteoarthritis of knee or hip for greater than (>) or equal to (=) 1 year (based on the American College of Rheumatology (ACR) diagnostic criteria for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (>=50 millimeter [mm] in 100 mm Visual Analog Scale [VAS])

• On any Cyclooxygenase - 2 (COX-2) inhibitors for at least 2 weeks preceding the study

• Women with childbearing potential must have negative pregnancy test

• Women of child bearing potential must agree to use accepted methods of contraception

• Participant has signed the written informed consent form

Exclusion Criteria:

• Participants taking Monoamine oxydase (MAO) inhibitors, neuroleptics or drugs for seizures

• Severe hepatic impairment (the impaired ability of the liver to fulfill its role in metabolism)

• On maintenance tramadol and/or paracetamol(APAP)

• On sedative hypnotics, short-acting analgesics, topical medications and anesthetics, and/or muscle relaxants

• Pregnant, lactating or breastfeeding participants