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

NCT ID: NCT01728246

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-05-31

Brief 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).

Detailed 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tramadol/Paracetamol (APAP)

Group Type: EXPERIMENTAL

Tramadol/Paracetamol (APAP)

Intervention Type: DRUG

Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy.

Non-Tramadol/APAP

Group Type: ACTIVE_COMPARATOR

Non-Tramadol/APAP

Intervention Type: DRUG

Celecoxib 200 mg alone once daily for 4 weeks.

Interventions

Tramadol/Paracetamol (APAP)

Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy.

Intervention Type: DRUG

Non-Tramadol/APAP

Celecoxib 200 mg alone once daily for 4 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica Clinical trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica

Locations

Janssen Philippines

Paranaque City, National Capital Region, Philippines

Countries

Philippines

Other Identifiers

TRAMAPNAP4002

Identifier Type: -

Identifier Source: secondary_id

CR013696

Identifier Type: -

Identifier Source: org_study_id