Status unknownNCT01009671Updated Nov 9, 2009

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

A Phase 3 interventional study of ART 44 and ART 50 in Knee Osteoarthritis, sponsored by Laboratoires NEGMA. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-11-09.

Sponsored by Laboratoires NEGMA (part of Wockhardt) · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2009), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 210
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study 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).

Conditions studied

Knee Osteoarthritis

Browse trials for

Osteoarthritis, Knee 3,391

Keywords

knee osteoarthritis

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 210 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Laboratoires NEGMA is the lead sponsor of 4 studies on the registry; none are open to participants now.

First submitted after Laboratoires NEGMA became part of Wockhardt.

Browse Laboratoires NEGMA studies →All Wockhardt studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Associated predominant symptomatic femoropatellar osteoarthritis;
Chondromatosis or villonodular synovitis of the knee;
Paget's Disease.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 210 participants (actual)

Study arms

Experimental
ART 44
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
Drug: ART 44
Active comparator
ART 50
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
Drug: ART 50

Interventions

DrugART 44
DrugART 50

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2009, a primary completion of Aug 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 6, 2009
First posted: Nov 9, 2009
Start: Nov 2009
Primary completionEst.: Aug 2010
CompletionEst.: Oct 2010
Last update: Nov 9, 2009

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01009671
Lead sponsor: Laboratoires NEGMA
First posted: Nov 9, 2009
Start date: Nov 2009
Primary completion: Aug 2010 (estimated)
Completion: Oct 2010 (estimated)
Last update: Nov 9, 2009

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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