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

Randomised, Comparative, Double-blind, Parallel-group Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009671

Enrollment

210

Registered

2009-11-09

Start date

2009-11-30

Completion date

2010-10-31

Last updated

2009-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis

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).

Interventions

DRUGART 44

DRUGART 50

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026