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

February 6, 2013 updated by: Janssen Pharmaceutica

A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

473

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Metro Manila
      • Paranaque City, Metro Manila, Philippines, 1700
        • Janssen Philippines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tramadol/Paracetamol (APAP)
Drug: 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.
Active Comparator: Non-Tramadol/APAP
Drug: Non-Tramadol/APAP
Celecoxib 200 mg alone once daily for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2
Time Frame: Baseline and Week 2
VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and Week 2
Change From Baseline in VAS-pain Score at Week 4
Time Frame: Baseline and Week 4 Last Observation Carried Forward (LOCF)
VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and Week 4 Last Observation Carried Forward (LOCF)
Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2
Time Frame: Baseline and Week 2
The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.
Baseline and Week 2
Change From Baseline in ODI Score at Week 4
Time Frame: Baseline and Week 4 (LOCF)
The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.
Baseline and Week 4 (LOCF)
Percentage of Participants Who Discontinued Because of Rescue Medication
Time Frame: Baseline up to Week 4
Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.
Baseline up to Week 4
Time to Discontinuation Because of Rescue Medication
Time Frame: Baseline up to Week 4
Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.
Baseline up to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 19, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013696
  • TRAMAPNAP4002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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