Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee

Randomised, Comparative, Double-blind, Parallel-group Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee

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

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: ART 44; Drug: ART 50

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ART 44; Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12	Drug: ART 44
Active Comparator: ART 50; Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12	Drug: ART 50

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the overall safety and efficacy of the two products	Day 8, Day 0, Week 2, Week 4 and Week 12

Collaborators and Investigators

• Sponsor: Laboratoires NEGMA

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: November 6, 2009
• First Submitted That Met QC Criteria: November 6, 2009
• First Posted (Estimate): November 9, 2009

Study Record Updates

• Last Update Posted (Estimate): November 9, 2009
• Last Update Submitted That Met QC Criteria: November 6, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: knee osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HEC/ARTGT/081000N; 2009-009990-84

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No