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

This study has been terminated.
(The study was stopped early due to recruitment challenges)
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 28, 2011
Last updated: May 28, 2015
Last verified: May 2015

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).

Condition Intervention Phase
Opioid-Induced Constipation
Drug: NKTR-118
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Response (Responder/Non-responder) to Study Drug [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]
    Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.

Enrollment: 14
Study Start Date: June 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 (part A and B)
Oral treatment
Drug: NKTR-118
12.5 mg oral tablet once daily
Experimental: 2 (part A and B)
Oral treatment
Drug: NKTR-118
25 mg oral tablet once daily
Placebo Comparator: 3 (part A only)
Oral treatment
Drug: Placebo
Oral treatment


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01384292

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Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01384292     History of Changes
Other Study ID Numbers: D3820C00006  2011-001985-16 
Study First Received: June 28, 2011
Results First Received: October 13, 2014
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Slovakia: State Institute for Drug Control
South Africa: Medicine Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency (ANM)
Poland: Ministry of Health and Social Welfare
Croatia: Agency for Medicinal Product and Medical Devices

Keywords provided by AstraZeneca:
Cancer-Related Pain
Opioid-Induced Constipation

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive processed this record on May 04, 2016