A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Product in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

  • STATUS
    Recruiting
Updated on 25 March 2021

Summary

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Product in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Description

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Product in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Patient Inclusion Criteria:

  • Provision of written informed consent prior to any study-specific procedures.
  • Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing =1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
  • Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
  • Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a BM has not occurred within at least 72 hours of the last recorded BM.

Patient Exclusion Criteria:

  • Patients receiving Opioid regimen for treatment of pain related to cancer.
  • History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
  • Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
  • Other issues to the gastrointestinal tract that could impose a risk to the patient.
  • Pregnancy or lactation.

Details
Clinical Study IdentifierTX135276
Last Modified on25 March 2021

Eligibility

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  • 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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