Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments art 44, art 50
Phase phase 3
Sponsor Laboratoires NEGMA
Start date November 2009
End date August 2010
Trial size 210 participants
Trial identifier NCT01009671, 2009-009990-84, HEC/ARTGT/081000N

Summary

The primary objective of this study, comparing ART 44 to ART 50, will be the evaluation of digestive tolerability (and in particular of diarrhoea).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
art 44
(Active Comparator)
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
art 50

Primary Outcomes

Measure
To demonstrate the better digestive tolerability of ART44 versus ART 50 over a 1-month period, based on a clinically predetermined difference
time frame: Day 8, Day 0, Week 2, Week 4 and Week 12

Secondary Outcomes

Measure
To compare the overall safety and efficacy of the two products
time frame: Day 8, Day 0, Week 2, Week 4 and Week 12

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Female or Male, aged 40 to 80 years, outpatient; - Presenting with internal femorotibial osteoarthritis: - Symptomatic for more than 6 months; - Meeting ACR clinical and radiological criteria; - Overall mean VAS score of knee pain in last 24 hours > 40 mm (with no NSAIDs for over 72 hours and no analgesics for over 24 hours); - Pain present for at least one day out of 2 in the month preceding enrolment; - Radiological stage II to III (Kellgren and Lawrence) (image less than 12 months old). Exclusion Criteria: - Associated predominant symptomatic femoropatellar osteoarthritis; - Chondromatosis or villonodular synovitis of the knee; - Paget's Disease.

Additional Information

Official title Randomised, Comparative, Double-blind, Parallel-group Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by Laboratoires NEGMA.