Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Opioid-Induced Constipation

In brief

The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR). The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).

Key facts

Study ID: NCT01384292
Run by: AstraZeneca
People needed: 14
Starts: 2011-06-01
Expected to finish: 2012-09-01
Last updated by the study team: 2015-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of written informed consent prior to any study-specific procedures.
Men and women aged 18 or older.
Histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids.
Self-reported active symptoms of OIC at screening (<3 RFBMs/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 RFBMs/week on average aver the 2-week OIC confirmation period.
Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.

You may not qualify if…

Patients receiving Opioid regimen for treatment of pain other than related to cancer.
Any condition that may have affected the permeability of the blood-brain barrier, eg, known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy.
Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are excluded. Patients with multiple myeloma will be allowed.
Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with suspected clinically relevant radiation-induced injury of small or large intestine are excluded.
Pregnancy or lactation.

Where it is running

Research Site — Casa Grande, Arizona, United States
Research Site — Phoenix, Arizona, United States
Research Site — Tucson, Arizona, United States
Research Site — Fort Smith, Arkansas, United States
Research Site — Hot Springs, Arkansas, United States
Research Site — North Little Rock, Arkansas, United States
Research Site — Encino, California, United States
Research Site — Fountain Valley, California, United States
Research Site — Gilroy, California, United States
Research Site — Laguna Hills, California, United States
Research Site — Montebello, California, United States
Research Site — Orange, California, United States
Research Site — Riverside, California, United States
Research Site — San Bernardino, California, United States
Research Site — Aurora, Colorado, United States
Research Site — Denver, Colorado, United States
Research Site — Baypines, Florida, United States
Research Site — Boynton Beach, Florida, United States
Research Site — Celebration, Florida, United States
Research Site — Clearwater, Florida, United States
Research Site — Coral Gables, Florida, United States
Research Site — Hialeah, Florida, United States
Research Site — Jacksonville, Florida, United States
Research Site — Lake Worth, Florida, United States
Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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