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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384292
Recruitment Status : Terminated (The study was stopped early due to recruitment challenges)
First Posted : June 29, 2011
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Opioid-Induced Constipation Drug: NKTR-118 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Naloxegol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response (Responder/Non-responder) to Study Drug [ Time Frame: Baseline to Week 4 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384292

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Sponsors and Collaborators
Additional Information:
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Responsible Party: AstraZeneca Identifier: NCT01384292    
Other Study ID Numbers: D3820C00006
First Posted: June 29, 2011    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015
Keywords provided by AstraZeneca:
Cancer-Related Pain
Opioid-Induced Constipation
Additional relevant MeSH terms:
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Opioid-Induced Constipation
Cancer Pain
Signs and Symptoms, Digestive
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neurologic Manifestations
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents