A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation

Description

The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation.

Inclusion Criteria:

  • 18 to 70 years of age
  • BMI of 19 to 35 kg/m2 at screening
  • Receiving prescribed opioid medication for the management of chronic, non-cancer, pain
  • Diagnosis of opioid-induced constipation (OIC)
  • Willingness to stop all laxatives and other bowel regimens from the first study visit following screening until the end of the study. The use of constipation rescue medication will be allowed during the study.

Exclusion Criteria:

  • Pregnancy and/or currently breastfeeding
  • Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)
  • Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction
  • Any GI or pelvic disorder known to affect bowel transit, produce a GI obstruction, or contribute to bowel dysfunction other than opioid-induced constipation (eg, diverticulitis, other intestinal strictures, bezoars)
  • Use of medical devices such as pacemakers, infusion pumps, or insulin pumps
  • Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study
  • Participation in a clinical trial of a pharmacological agent within 30 days before screening

Details
Clinical Study IdentifierTX134982
Last Modified on8 November 2020

Eligibility

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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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