Pioglitazone and ulceritive colitis

Phase 2

• Conditions: lceritive colitis.; Ulcerative colitis, unspecified

• Registration Number: IRCT201103035867N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) mayo score between 4 to 10 2) patients have been treated with 5-aminosalicylic acid (5-ASA) compounds at a dose of 2000 mg per day or greater for at least 4 weeks immediately prior to randomization or to have documented intolerance to such therapy.3) concomitant therapy with corticosteroids was permitted if the dose was stable for a minimum of 4 weeks prior to randomization and did not exceed prednisone 20mg per day, budesonide 9mg per day, or the equivalent. 4)Concomitant therapy with azathioprine or 6-mercaptopurine was allowed if used for a minimum of 4 months and at a stable dose for a minimum of 2 months prior to randomization.5) rectally administered corticosteroids or 5-ASA was allowed if the dose was stable for two weeks prior to randomization
Exclusion criteria:
1)pregnancy breast feeding 2)stage 3 or 4 of congestive heart failure based on new york criteria 3) liver disease 4) renal failure 5) BMI>35 6) diabetic patient requiring treatment 7) colitis with other causes 8) patients with contraindications for colonoscopy 9) antidiarhial agent

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment. Timepoint: Begining/after 12 week. Method of measurement: 2 score decrease in mayo score.

Secondary Outcome Measures

Name	Time	Method
Response to treatment. Timepoint: Begining/ after 12 week. Method of measurement: 3 score reduction in mayo score.;Quality of life. Timepoint: Begining/after 4 8 12 month. Method of measurement: Inflammatory Bowel Disease Questionnaire.;Clinical remission. Timepoint: After 12 week. Method of measurement: Mayo score.;Endoscopic remission. Timepoint: After 12 week. Method of measurement: Mayo score.;Possible side effect. Timepoint: After 4 8 12 week. Method of measurement: Patients medical records.