Status:
COMPLETED
Laquinimod Phase IIa Study in Active Crohn's Disease
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg ...
Eligibility Criteria
Inclusion
- Subjects diagnosed with Crohn's disease for at least 3 months prior to screening.
- Moderate to severe Crohn's disease patients as determined by the CDAI score
Exclusion
- Subjects who have had recent bowel surgery
- Subjects with clinically significant GI obstructive symptoms
- Subjects with a clinically significant or unstable medical or surgical condition
- Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants )
- Women who are pregnant or nursing or who intend to be during the study period.
- Women of child-bearing potential who do not practice an acceptable method of birth control
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00737932
Start Date
May 1 2010
End Date
December 1 2011
Last Update
March 20 2015
Active Locations (34)
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1
Teva Investigational Site 3711
Bonheiden, Belgium
2
Teva Investigational Site 3712
Leuven, Belgium
3
Teva Investigational Site 3713
Roeselare, Belgium
4
Teva Investigational Site 5351
Amiens, France