Stamford Therapeutics Consortium

Opioid-Induced Constipation

Stamford Therapeutics Consortium is currently conducting a study on
Opioid-Induced Constipation sponsored by AstraZeneca


Summary: The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

For More Information Please Contact:
Judy Dalgin (Site Manager)
email: jdalgin@stctrials.com
telephone: 203-325-8529



Eligibility:

  • Ages Eligible for Study: 18 Years to 84 Years

  • Genders Eligible for Study: Both

  • Accepts Healthy Volunteers: No

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.


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.
Stamford Therapeutics Consortium

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