Research study for volunteers at least 18 years of age who are currently experiencing symptoms of chronic constipation

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

Research study for volunteers at least 18 years of age who are currently experiencing symptoms of chronic constipation

Description

This is a research study for chronic idiopathic constipation. Subjects who meet the inclusion criteria will be entered into up to a 9 day treatment period. Patients will either receive the product under study or the marketed equivalent or placebo. Medication will be administered orally twice daily.

Patient Inclusion Criteria:

  • Male and non-pregnant females 18 years of age and older
  • Chronic idiopathic constipation defined as, on average <3 bowel movements per week for the past 6 months
  • Confirmation of chronic constipation by a daily diary during the 14 day lead-in period

  • Pregnancy or breast feeding
  • Documented bowel obstruction
  • Crohn’s disease, ulcerative colitis
  • History of bowel resection
  • Regular use of medications known to cause constipation
  • Unstable hypothyroidism, Parkinson’s disease, multiple sclerosis or spinal cord disorder
  • Any hospitalization for any gastrointestinal or abdominal surgical procedure 3 months prior to dosing

Patient Exclusion Criteria:

Details
Clinical Study IdentifierTX135472
Last Modified on8 November 2020

Eligibility

How to participate?

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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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