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

May 28, 2015 updated by: AstraZeneca

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia
        • Research Site
    • Victoria
      • Frankston, Victoria, Australia
        • Research Site
      • Malvern, Victoria, Australia
        • Research Site
      • Parkville, Victoria, Australia
        • Research Site
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Mons, Belgium
        • Research Site
      • Wetteren, Belgium
        • Research Site
  • Bulgaria
      • Haskovo, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Shumen, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Croatia
      • Zagreb, Croatia
        • Research Site
  • Czech Republic
      • Benesov, Czech Republic
        • Research Site
      • Ceske Budejovice, Czech Republic
        • Research Site
      • Praha 2, Czech Republic
        • Research Site
  • Germany
      • Offenbach, Germany
        • Research Site
    • BE
      • Berlin, BE, Germany
        • Research Site
    • HE
      • Wiesbaden, HE, Germany
        • Research Site
    • HH
      • Hamburg, HH, Germany
        • Research Site
  • Poland
      • Brzozow, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Gliwice, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Warsaw, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
  • Puerto Rico
      • Ponce, Puerto Rico
        • Research Site
  • Romania
      • Baia Mare, Romania
        • Research Site
      • Braila, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
      • Cluj-napoca, Romania
        • Research Site
      • Onesti, Romania
        • Research Site
    • Dolj
      • Craiova, Dolj, Romania
        • Research Site
    • Prahova
      • Ploiesti, Prahova, Romania
        • Research Site
  • Slovakia
      • Bardejov, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa
        • Research Site
    • Free State
      • Bloemfontein, Free State, South Africa
        • Research Site
    • Gauteng
      • Benoni, Gauteng, South Africa
        • Research Site
      • Pretoria, Gauteng, South Africa
        • Research Site
      • Vereeniging, Gauteng, South Africa
        • Research Site
    • Kz-natal
      • Durban, Kz-natal, South Africa
        • Research Site
    • W Cape
      • Goodwood, W Cape, South Africa
        • Research Site
  • Spain
    • Andalucia
      • Sevilla, Andalucia, Spain
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain
        • Research Site
    • Galicia
      • A Coruna, Galicia, Spain
        • Research Site
  • United Kingdom
      • Coventry, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
    • CRF
      • Penarth, CRF, United Kingdom
        • Research Site
    • Norfolk
      • Norwich, Norfolk, United Kingdom
        • Research Site
    • Surrey
      • Guildford, Surrey, United Kingdom
        • Research Site
    • Wilts
      • Chippenham, Wilts, United Kingdom
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Research Site
    • Arizona
      • Casa Grande, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Fort Smith, Arkansas, United States
        • Research Site
      • Hot Springs, Arkansas, United States
        • Research Site
      • North Little Rock, Arkansas, United States
        • Research Site
    • California
      • 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 Bernandino, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
      • Denver, Colorado, United States
        • Research Site
    • Florida
      • 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
      • Lakeland, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Miami Lakes, Florida, United States
        • Research Site
      • Naples, Florida, United States
        • Research Site
      • Plantation, Florida, United States
        • Research Site
      • Tavares, Florida, United States
        • Research Site
    • Georgia
      • Albany, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
      • Riverdale, Georgia, United States
        • Research Site
      • Roswell, Georgia, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Springfield, Illinois, United States
        • Research Site
    • Indiana
      • Anderson, Indiana, United States
        • Research Site
      • Evansville, Indiana, United States
        • Research Site
    • Kentucky
      • Owensboro, Kentucky, United States
        • Research Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • Research Site
    • Maryland
      • Elkridge, Maryland, United States
        • Research Site
      • Hollywood, Maryland, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
      • Fairhaven, Massachusetts, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
      • Kalamazoo, Michigan, United States
        • Research Site
    • Mississippi
      • Southaven, Mississippi, United States
        • Research Site
    • Missouri
      • Jefferson City, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Missoula, Montana, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Toms River, New Jersey, United States
        • Research Site
      • Voorhees, New Jersey, United States
        • Research Site
    • New York
      • Great Neck, New York, United States
        • Research Site
      • Syracuse, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • Flat Rock, North Carolina, United States
        • Research Site
      • Morrisville, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
      • Winston-salem, North Carolina, United States
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Beavercreek, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Middleton, Ohio, United States
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
    • Texas
      • Beaumont, Texas, United States
        • Research Site
      • Bellaire, Texas, United States
        • Research Site
      • Corpus Christi, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Lubbock, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Sugarland, Texas, United States
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 (part A and B)
Oral treatment
Drug: NKTR-118
25 mg oral tablet once daily
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
Drug: NKTR-118
12.5 mg oral tablet once daily
Placebo Comparator: 3 (part A only)
Oral treatment
Drug: Placebo
Oral treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3820C00006
  • 2011-001985-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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