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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ART 44

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

Group Type EXPERIMENTAL

ART 44

Intervention Type DRUG

ART 50

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

Group Type ACTIVE_COMPARATOR

ART 50

Intervention Type DRUG

Interventions

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ART 44

Intervention Type DRUG

ART 50

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires NEGMA

INDUSTRY

Sponsor Role lead

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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