Ulcerative Colitis

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

Ulcerative Colitis

Description

000175 : A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis.

Details
Condition Ulcerative Colitis
Clinical Study IdentifierTX141653
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

Exclusion Criteria

Evidence of other forms of inflammatory bowel disease
Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
Disease limited to proctitis <15 cm
Short bowel syndrome
Prior colon resection surgery
History of severe/fulminant UC
Intolerant or allergic to aspirin or salicylate derivatives
Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
Women who are pregnant or nursing
History of known malignancy
History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/ emotional disorders, that would interfere with their participation in the trial
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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