Irritable Bowel Syndrome with Constipation (IBS-C)

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

Irritable Bowel Syndrome with Constipation (IBS-C)

Description

SP304203-04 : Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IIBS-C).

Details
Condition Irritable Bowel Syndrome (IBS)
Clinical Study IdentifierTX141639
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria

Refusal or inability to sign informed consent for the trial
Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
BMI > 35 or < 18
Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
Women who are pregnant or lactating
Diagnosis of IBS-D or IBS-M
Organic or obstructive disease of the small or large intestine
Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
Unstable medical illness
Bilirubin > 3X ULN in the absence of a conjugation defect
Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
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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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