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

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid-Induced Constipation (OIC)

In brief

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).

Key facts

Study ID

NCT01309841

Run by

AstraZeneca

People needed

652

Starts

2011-03-01

Expected to finish

2012-08-01

Last updated by the study team

2015-06-01

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Calera, Alabama, United States
• Research Site — Glendale, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Hot Springs, Arkansas, United States
• Research Site — Malvern, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Beverly Hills, California, United States
• Research Site — Burbank, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — Laguana Hills, California, United States
• Research Site — Laguna Hills, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Gatos, California, United States
• Research Site — Montebello, California, United States
• Research Site — National City, California, United States
• Research Site — Norwalk, California, United States
• Research Site — Paramount, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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