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

A Phase 3 study testing ART 44 and ART 50 in people with Knee Osteoarthritis, run by Laboratoires NEGMA.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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). Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: ART 44 and ART 50
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: No sites listed yet
Study dates: Nov 2009to Oct 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

About this study

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

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: Knee Osteoarthritis
Being tested: ART 44, ART 50
Keywords: knee osteoarthritis
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ART 44Drug
ART 50Drug

Study groups in NCT01009671
Study group	Role	What they receive
ART 44	Experimental	Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12 Receives: Drug: ART 44
ART 50	Active comparator	Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12 Receives: Drug: ART 50

What is being measured

The primary outcome is the main question the study is designed to answer.

To demonstrate the better digestive tolerability of ART44 versus ART 50 over a 1-month period, based on a clinically predetermined difference
Measured: Day 8, Day 0, Week 2, Week 4 and Week 12

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Oct 2010

First posted9 Nov 2009 (estimated)
Study startNov 2009
Primary completionAug 2010 (estimated)
Study completionOct 2010 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01009671
Sponsor's protocol ID: HEC/ARTGT/081000N
Other IDs: 2009-009990-84, 2009
Status last verified: Nov 2009
First submitted: 6 Nov 2009
Last updated: 9 Nov 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01009671
Acronym / sponsor ID: HEC/ARTGT/081000N
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 210 participants (actual)
Lead sponsor: Laboratoires NEGMAIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Aug 2010 (estimated)
Study completion: Oct 2010 (estimated)
First posted: 9 Nov 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

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

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female or Male, aged 40 to 80 years, outpatient;
Presenting with internal femorotibial osteoarthritis:

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ART 44	Drug	ART 44
ART 50	Drug	ART 50

Primary outcome

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

1 secondary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2009.

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ART 44 and ART 50 in people with Knee Osteoarthritis, run by Laboratoires NEGMA.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009671.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2009.