Study to Evaluate the Digestive Tolerability of ART44 Ver... | NCT01009671

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

NCT01009671

Sponsor

Laboratoires NEGMA

Status

Unknown status

Last Update Posted

Nov 9, 2009Estimated

Enrollment

210Actual

Phase

Phase 3

Conditions

Knee Osteoarthritis

Interventions

ART 44
ART 50

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-009990-84

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Aug 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Nov 6, 2009

First Submission Date that Met QC Criteria

Nov 6, 2009

First Posted Date

Nov 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2009

Last Update Posted Date

Nov 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ART 44	Experimental	Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12	Drug: ART 44
ART 50	Active Comparator	Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12	Drug: ART 50

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ART 44	Drug		ART 44
ART 50

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Mar 27, 2012
Reset	Apr 18, 2012
Release	May 9, 2012
Reset	Jun 12, 2012
Release	Jun 12, 2012
Reset	Jul 13, 2012

Submission Tracking

Estimated Results First Submitted Date

Mar 27, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 27, 2012			Apr 18, 2012
May 9, 2012

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided