Overview

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

Status:
Completed
Trial end date:
2012-09-01
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.

- 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.