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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Opioid-Induced Constipation (OIC)

Treatments

Drug: NKTR-118

Drug: Usual care

Study type

Interventional

Funder types

Industry

Identifiers

NCT01336205

D3820C00008

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.

Enrollment

844 patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of written informed consent prior to any study-specific procedures.
NEW PATIENTS ONLY: 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 the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 related to the gastrointestinal tract that could impose a risk to the patient.
Pregnancy or lactation.