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

Laboratoires NEGMA

Status and phase: Unknown; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: ART 44; Drug: ART 50

Study type: Interventional

Funder types: Industry

Identifiers

NCT01009671

2009-009990-84

HEC/ARTGT/081000N

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups

ART 44

Experimental group

Description:

Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12

Treatment:

Drug: ART 44

ART 50

Active Comparator group

Description:

Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12

Treatment:

Drug: ART 50