Last updated on November 2017

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)


Brief description of study

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)

Detailed Study 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.

Clinical Study Identifier: TX1352

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Suzi DeFiesta

CSI Research Inc
Alpharetta, GA USA
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