Trial intelligence / Profile preview

Efficacy of Diacerein in Knee Osteoarthritis

NCT00445276Phase 4

Key facts

Status
Completed
Start
Nov 2005
Primary completion
Sep 2006
Countries
1
Modality
DNA Intercalators/Alkylators
Conditions
knee osteoarthritis (OA)
01

Overview

Phase 4, randomised, double-blind trial of diacerein in knee osteoarthritis (OA) (2 arms), sponsored by Negma Group. Primary endpoints: Visual Analog Scale on pain movement and Western Ontario and McMaster Universities Osteoarthritis Index Section A 1.1. Started Nov 2005; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Diacerein

    Diacerein treatment

  • Control

    Placebo or Active Control

03

Endpoints

Primary

  • Visual Analog Scale on pain movement

  • Western Ontario and McMaster Universities Osteoarthritis Index Section A 1.1

Secondary

  • Western Ontario and McMaster Universities Osteoarthritis Index Total Score

  • Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale

  • Western Ontario and McMaster Universities Osteoarthritis Index Physical Function Subscale

  • Paracetamol consumption

  • Global assessment of the patient

  • Responder patients with OMERACT-OARSI criteria

  • Tolerance

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