NCT01009671

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P50-P75 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3 knee-osteoarthritis

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

9 months

First QC Date

November 6, 2009

Last Update Submit

November 6, 2009

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • To compare the overall safety and efficacy of the two products

    Day 8, Day 0, Week 2, Week 4 and Week 12

Study Arms (2)

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

ART 44DRUG
ART 44
ART 50DRUG
ART 50

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

November 9, 2009

Record last verified: 2009-11