Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Analgesics, Opioid; Naloxegol

Criteria

Inclusion Criteria:

• Provision of written informed consent prior to any study-specific procedures.

• Men and women who are between the ages of ≥18 and <85 years.

• 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.