Volunteers needed, experiencing Irritable Bowel Syndrome (IBS) with constipation to participate in a research study.

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

Volunteers needed, experiencing Irritable Bowel Syndrome (IBS) with constipation to participate in a research study.

Description

23 week study comparing an oral investigational medication versus placebo (inactive substance) administered once daily in male and female subjects 18 years of age and older.

Inclusion Criteria:

  • Have access to a touch-tone phone for the duration of the study to complete daily diary calls.
  • Abdominal pain or discomfort that has 2 or more of the following for at least 12 weeks, which need not be consecutive, in the 12 months before the Screening Visit:
    • Relieved with defecation
    • Onset associated with a change in frequency of stool
    • Onset associated with a change in appearance of stool
  • Fewer than 3 bowel movements a week, without the use of laxatives, and 1 or more of the following symptoms for at least 12 weeks, which need not be consecutive, in the 12 months before Screening Visit:
    • Straining during more than 25% of bowel movements
    • Lumpy or hard stools during more than 25% of bowel movements
    • Sensation of incomplete evacuation during more than 25% of bowel movements
  • Be willing to discontinue laxative use during the study visit in favor of the study-defined rescue medication

Exclusion Criteria:

  • Report loose or watery stools for more than 25% of bowel movements during the 12 weeks prior to screening.
  • Bariatric surgery (surgery for obesity), surgery of the abdomen, pelvis or retroperitoneal structures 6 months prior to Screening. Appendectomy or cholecystectomy 60 days prior to Visit 1.
  • Gastrointestinal bleeding, iron deficient anemia, colitis, diverticulits, chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis or active peptic ulcer disease.
  • Use of narcotics, non steroidal anti-inflammatory medication for abdominal pain or discomfort, or any medication used for weight loss.

Details
Clinical Study IdentifierTX134555
Last Modified on8 November 2020

Eligibility

How to participate?

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.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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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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