Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee
NCT ID: NCT01009671
Last Updated: 2009-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
210 participants
INTERVENTIONAL
2009-11-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ART 44
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
ART 44
ART 50
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
ART 50
Interventions
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ART 44
ART 50
Eligibility Criteria
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Inclusion Criteria
* 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
* Chondromatosis or villonodular synovitis of the knee;
* Paget's Disease.
40 Years
80 Years
ALL
No
Sponsors
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Laboratoires NEGMA
INDUSTRY
Responsible Party
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Laboratoires NEGMA
Other Identifiers
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2009-009990-84
Identifier Type: -
Identifier Source: secondary_id
HEC/ARTGT/081000N
Identifier Type: -
Identifier Source: org_study_id
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