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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01009671
• Other study ID #: HEC/ARTGT/081000N
• Secondary ID: 2009-009990-84
• Status: Unknown status
• Phase: Phase 3
• First received: November 6, 2009
• Last updated: November 6, 2009
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2009
• Source: Laboratoires NEGMA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 210
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• ART 44

• ART 50

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires NEGMA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the overall safety and efficacy of the two products		Day 8, Day 0, Week 2, Week 4 and Week 12