A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis

Labopharm Inc.0 sites1,028 target enrollmentOctober 2004

ConditionsPain Osteoarthritis

InterventionsTramadol Once a day Placebo

DrugsTramadol Once a day Placebo

Overview

Phase: Phase 3
Intervention: Tramadol Once a day
Conditions: Pain
Sponsor: Labopharm Inc.
Enrollment: 1028
Primary Endpoint: Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the analgesic efficacy, safety and clinical benefit of Tramadol OAD tablets versus Placebo.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

January 2006

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Labopharm Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1 Tramadol Once A Day

Intervention: Tramadol Once a day

2 Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)

Time Frame: 12 weeks

The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.

Secondary Outcomes

Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)(week 12)
Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment(6 weeks)
Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)(12 weeks)
Time to Response(12 weeks)
Discontinuation Due to Lack of Efficacy(12 weeks)
Discontinuation Due to Adverse Events(12 weeks)