Clinical trial NCT01384292: Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Opioid-Induced Constipation
Keywords: Cancer-Related Pain
Opioid-Induced Constipation
OIC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Response (Responder/Non-responder) to Study Drug
timeFrame: Baseline to Week 4
Secondary outcomes:
Other outcomes:
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state: Comunidad Valenciana
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city: Chippenham
country: United Kingdom
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state: Wilts
city: Coventry
country: United Kingdom
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city: London
country: United Kingdom
facility: Research Site
Study officials:
References: