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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Treatments

Drug: Tramadol/Paracetamol (APAP)

Drug: Non-Tramadol/APAP

Study type

Interventional

Funder types

Industry

Identifiers

NCT01728246

CR013696

TRAMAPNAP4002

Details and patient eligibility

About

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).

Full description

This is an open-label (all people know the identity of the intervention), randomized (study drug assigned by chance), controlled study to evaluate the efficacy, safety and effects on QOL of tramadol/APAP as an add-on therapy in Filipino participants suffering from chronic pain because of chronic osteoarthritis. Participants will be randomly assigned to 2 groups: tramadol/APAP group and non tramadol/APAP group. Participants in tramadol/APAP group will receive celecoxib 200 milligram (mg) and fixed dose combination of tramadol (37.5 mg)/APAP (325 mg) as add on therapy, while the participants in non-tramadol/APAP group will receive celecoxib 200 mg only. The total duration of the study will be 4 weeks. The participants in both the groups will be given celecoxib 200 mg once daily for 4 weeks. In addition, the participants in the tramadol/APAP group will be given add-on tramadol/APAP doses 3 times a day for 4 weeks. Participants will be asked to return for follow-up at Weeks 2 and 4. Efficacy will be assessed using 100 millimeter (mm) Visual Analog Scale (VAS) while QOL will be assessed using the Oswestry Disability Index (ODI). Participant safety will be monitored throughout the study.

Enrollment

473 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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