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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.