Trial intelligence / Profile preview

Tramadol Once-a-Day in Osteoarthritis of the Knee

NCT00833794Phase 3

Key facts

Status: Completed
Start: Oct 2004
Primary completion: Jan 2006
Sponsor: Labopharm Inc.
Modality: Small Molecules

Drugs: tramadol
Conditions: osteoarthritis (OA)

Overview

Phase 3, randomised, double-blind trial in osteoarthritis (OA) comparing Tramadol Once A Day with Placebo (2 arms). Primary endpoint: Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at 12 weeks. Started Oct 2004; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Tramadol Once A Day
Tramadol Once-a-Day tablets
Placebo
Placebo tablets

Who it enrols

Patients aged 40-80 with osteoarthritis of the knee, current knee pain, and a history of response to NSAIDs or tramadol. Must have a pain score >= 4 and a flare upon washout of prior medications.

Endpoints

Primary

Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score12 weeks

Secondary

Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment6 weeks
WOMAC Pain Subscale Score12 weeks
WOMAC Physical Function Subscale Score12 weeks
Patient Global Impression of Change12 weeks
Physician Global Impression of Change12 weeks
Time to Response12 weeks
Discontinuation Due to Lack of Efficacy12 weeks
Discontinuation Due to Adverse Events12 weeks

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