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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01059344 |
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Date of registration:
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28/01/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
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Scientific title:
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A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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281 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01059344 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Belarus
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India
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Turkey
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Ukraine
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Contacts
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Name:
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Brian Feagan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Robarts Clinical Trials Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
(1) Male or non-pregnant, non-lactating females, 18 years of age or older. (2) Documented
diagnosis of UC with disease extending at least 15 cm from the anal verge.
(3) Active UC defined by:
(a) modified UC-DAI score of 4-10 with (b) sigmoidoscopy component score = 2 and (c) rectal
bleeding component score = 1 (4) Ability of subject to participate fully in all aspects of
this clinical trial.
(5) Written informed consent must be obtained and documented.
Exclusion Criteria:
1. Severe UC defined by the following criteria:
³6 bloody stools daily with one or more of the following:
1. oral temperature > 37.8°C or > 100.0°F
2. pulse > 90/min
3. hemoglobin < 10 g/dL
2. Previously failed treatment with a mesalazine dose of > 2.0 g/day.
3. Current relapse lasting > 6 weeks in the opinion of the investigator.
4. Treatment with 5-ASA at a dose of >2.0g/day within 1 week prior to randomisation
5. Treatment with systemic or rectal steroids within 4 weeks prior to randomization.
6. Treatment with immunosuppressants within 6 weeks prior to randomization.
7. Treatment with infliximab or other biologics within 3 months prior to randomization.
8. Treatment with systemic antibiotics for UC within 7 days prior to randomization.
9. Treatment with probiotics within 7 days prior to randomization.
10. Treatment with anti-diarrheals within 7 days prior to randomization.
11. Treatment with nicotine patch within 7 days prior to randomization.
12. Received any investigational drug within 30 days prior to randomization.
13. History of colectomy or partial colectomy.
14. History of definite dysplasia in colonic biopsies.
15. Crohn's disease.
16. Known bleeding disorders.
17. Immediate or significant risk of toxic megacolon.
18. Hypersensitivity to salicylates, aspirin, sulfasalazine or 5-ASA.
19. Serum creatinine > 1.5 times the upper limit of the normal range.
20. AST, ALT, total bilirubin or alkaline phosphatase > 2 times the upper limit of the
normal range.
21. Serious underlying disease other than UC which in the opinion of the investigator may
interfere with the subject's ability to participate fully in the study.
22. History of alcohol or drug abuse which in the opinion of the investigator may
interfere with the subject's ability to comply with the study procedures.
23. Stools positive for clostridium difficile.
24. Pregnant or lactating women.
25. Prior enrolment in the current study and had received study treatment.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Mesalamin
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Primary Outcome(s)
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To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC).
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Clinical Remission
[Time Frame: 10 weeks]
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Improvement
[Time Frame: 6 weeks]
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Endoscopic Remission
[Time Frame: 6 weeks]
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Endoscopic Remission
[Time Frame: 10 weeks]
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Improvement
[Time Frame: 10 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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