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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ART 44
ART 50
Sponsored by
Laboratoires NEGMA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ART 44

    ART 50

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    To demonstrate the better digestive tolerability of ART44 versus ART 50 over a 1-month period, based on a clinically predetermined difference

    Secondary Outcome Measures

    To compare the overall safety and efficacy of the two products

    Full Information

    First Posted
    November 6, 2009
    Last Updated
    November 6, 2009
    Sponsor
    Laboratoires NEGMA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01009671
    Brief Title
    Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    August 2010 (Anticipated)
    Study Completion Date
    October 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laboratoires NEGMA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    knee osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    210 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ART 44
    Arm Type
    Experimental
    Arm Description
    Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
    Arm Title
    ART 50
    Arm Type
    Active Comparator
    Arm Description
    Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
    Intervention Type
    Drug
    Intervention Name(s)
    ART 44
    Intervention Type
    Drug
    Intervention Name(s)
    ART 50
    Primary Outcome Measure Information:
    Title
    To demonstrate the better digestive tolerability of ART44 versus ART 50 over a 1-month period, based on a clinically predetermined difference
    Time Frame
    Day 8, Day 0, Week 2, Week 4 and Week 12
    Secondary Outcome Measure Information:
    Title
    To compare the overall safety and efficacy of the two products
    Time Frame
    Day 8, Day 0, Week 2, Week 4 and Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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