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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Naloxegol
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01384292


  Show 140 Study Locations
Sponsors and Collaborators
AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01384292     History of Changes
Other Study ID Numbers: D3820C00006
2011-001985-16
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
OIC

Additional relevant MeSH terms:
Constipation
Cancer Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Naloxegol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists