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

NCT01728246 | Completed Phase 4 Results

• 2 other identifiers: CR013696TRAMAPNAP4002
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Celecoxib; Tramadol; Paracetamol

Outcome Measures

Primary Outcomes (6)

• Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at 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

  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

  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

  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

  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

  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

Study Arms (2)

Tramadol/Paracetamol (APAP)

EXPERIMENTAL

Drug: Tramadol/Paracetamol (APAP)

Non-Tramadol/APAP

ACTIVE COMPARATOR

Drug: Non-Tramadol/APAP

Interventions

Tramadol/Paracetamol (APAP) 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.

Tramadol/Paracetamol (APAP)

Non-Tramadol/APAP DRUG

Celecoxib 200 mg alone once daily for 4 weeks.

Non-Tramadol/APAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

Study Sites (1)

Janssen Philippines

Paranaque City, National Capital Region, 1700, Philippines

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Results Point of Contact

• Title: Medical Affairs Manager
• Organization: Janssen Pharmaceutica

+632-8247901

Study Officials

• Janssen Pharmaceutica Clinical trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 19, 2012
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: February 12, 2013
• Results First Posted: January 14, 2013

Record last verified: 2013-02

Locations

PH (1)