Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

October 13, 2014 updated by: AstraZeneca

An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain

The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

844

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

  • United States
    • Alabama
      • Athens, Alabama, United States
        • Research Site
      • Birmingham, Alabama, United States
        • Research Site
      • Huntsville, Alabama, United States
        • Research Site
      • Mobile, Alabama, United States
        • Research Site
      • Pell City, Alabama, United States
        • Research Site
    • Arizona
      • Garden Grove, Arizona, United States
        • Research Site
      • Goodyear, Arizona, United States
        • Research Site
      • Mesa, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
      • Tuscon, Arizona, United States
        • Research Site
    • Arkansas
      • Jonesboro, Arkansas, United States
        • Research Site
      • Little Rock, Arkansas, United States
        • Research Site
      • North Little Rock, Arkansas, United States
        • Research Site
      • Sherwood, Arkansas, United States
        • Research Site
    • California
      • Arcadia, California, United States
        • Research Site
      • Chino, California, United States
        • Research Site
      • Encino, California, United States
        • Research Site
      • Fremont, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • Huntington Park, California, United States
        • Research Site
      • La Mesa, California, United States
        • Research Site
      • Laguna Hills, California, United States
        • Research Site
      • Lakewood, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Oceanside, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • Pasadena, California, United States
        • Research Site
      • Riverside, California, United States
        • Research Site
      • San Bernardino, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
      • Whittier, California, United States
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States
        • Research Site
      • Bradenton, Florida, United States
        • Research Site
      • Brooksville, Florida, United States
        • Research Site
      • Chiefland, Florida, United States
        • Research Site
      • Clearwater, Florida, United States
        • Research Site
      • Crystal River, Florida, United States
        • Research Site
      • Daytona Beach, Florida, United States
        • Research Site
      • Debary, Florida, United States
        • Research Site
      • Deerfield Beach, Florida, United States
        • Research Site
      • Delray Beach, Florida, United States
        • Research Site
      • Edgewater, Florida, United States
        • Research Site
      • Eustis, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Inverness, Florida, United States
        • Research Site
      • Jackson, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Jupiter, Florida, United States
        • Research Site
      • Largo, Florida, United States
        • Research Site
      • Lauderhill, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Naples, Florida, United States
        • Research Site
      • North Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Orange City, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Oviedo, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
      • Pinellas Park, Florida, United States
        • Research Site
      • Plantation, Florida, United States
        • Research Site
      • Port Orange, Florida, United States
        • Research Site
      • Port St. Lucie, Florida, United States
        • Research Site
      • South Miami, Florida, United States
        • Research Site
      • St. Doral, Florida, United States
        • Research Site
      • St. Petersburg, Florida, United States
        • Research Site
      • Tamarac, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • West Palm, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Alpharetta, Georgia, United States
        • Research Site
      • Atlanta, Georgia, United States
        • Research Site
      • Columbus, Georgia, United States
        • Research Site
      • Marietta, Georgia, United States
        • Research Site
      • Suwanee, Georgia, United States
        • Research Site
      • Tucker, Georgia, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Illinois
      • Bloomington, Illinois, United States
        • Research Site
      • Chicago, Illinois, United States
        • Research Site
      • Peoria, Illinois, United States
        • Research Site
      • Schaumburg, Illinois, United States
        • Research Site
    • Indiana
      • Evansville, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Iowa
      • Council Bluffs, Iowa, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
      • Lansing, Kansas, United States
        • Research Site
      • Overland Park, Kansas, United States
        • Research Site
      • Wichita, Kansas, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Columbia, Maryland, United States
        • Research Site
      • Hollywood, Maryland, United States
        • Research Site
      • Pikesville, Maryland, United States
        • Research Site
      • Reisterstown, Maryland, United States
        • Research Site
    • Massachusetts
      • Watertown, Massachusetts, United States
        • Research Site
    • Michigan
      • Calamazoo, Michigan, United States
        • Research Site
      • Traverse City, Michigan, United States
        • Research Site
    • Missouri
      • St Louis, Missouri, United States
        • Research Site
      • St. Louis, Missouri, United States
        • Research Site
    • Nebraska
      • Bellevue, Nebraska, United States
        • Research Site
      • Fremont, Nebraska, United States
        • Research Site
      • Lincoln, Nebraska, United States
        • Research Site
      • Omaha, Nebraska, United States
        • Research Site
    • Nevada
      • Henderson, Nevada, United States
        • Research Site
      • Las Vegas, Nevada, United States
        • Research Site
    • New Jersey
      • Clifton, New Jersey, United States
        • Research Site
      • Freehold, New Jersey, United States
        • Research Site
      • Lumberton, New Jersey, United States
        • Research Site
      • Toms River, New Jersey, United States
        • Research Site
      • Voorhees, New Jersey, United States
        • Research Site
      • Willingboro, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Great Neck, New York, United States
        • Research Site
      • Hartsdale, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • North Massapequa, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Elkin, North Carolina, United States
        • Research Site
      • Flat Rock, North Carolina, United States
        • Research Site
      • Harrisburg, North Carolina, United States
        • Research Site
      • Mooresville, North Carolina, United States
        • Research Site
      • Morganton, North Carolina, United States
        • Research Site
      • Morrisville, North Carolina, United States
        • Research Site
      • Winston-salem, North Carolina, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Beavercreek, Ohio, United States
        • Research Site
      • Centerville, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Downingtown, Pennsylvania, United States
        • Research Site
      • Jenkintown, Pennsylvania, United States
        • Research Site
      • Norristown, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pottstown, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States
        • Research Site
      • Charleston, South Carolina, United States
        • Research Site
      • Greer, South Carolina, United States
        • Research Site
      • Myrtle Beach, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Clarksville, Tennessee, United States
        • Research Site
      • Jackson, Tennessee, United States
        • Research Site
      • Memphis, Tennessee, United States
        • Research Site
      • Milan, Tennessee, United States
        • Research Site
      • New Tazewell, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • Hurst, Texas, United States
        • Research Site
      • Lexington, Texas, United States
        • Research Site
      • Marshall, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
      • Sugarland, Texas, United States
        • Research Site
      • Victoria, Texas, United States
        • Research Site
    • Utah
      • Clinton, Utah, United States
        • Research Site
      • Ogden, Utah, United States
        • Research Site
      • Saint George, Utah, United States
        • Research Site
      • Salt Lake City, Utah, United States
        • Research Site
      • West Jordan, Utah, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
      • Springfield, Virginia, United States
        • Research Site
      • Virginia Beach, Virginia, United States
        • Research Site
    • Wisconsin
      • Middleton, Wisconsin, 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 to 84 years (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.
  • NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing >1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
  • PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
  • FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if BM has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

  • Patients receiving Opioid regimen for treatment of pain related to cancer.
  • History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
  • Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
  • Other issues related to the gastrointestinal tract that could impose a risk to the patient.
  • 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Oral Treatment
Drug: NKTR-118
25 mg oral tablet once daily
Active Comparator: 2
Oral treatment
Drug: Usual care
As prescribed by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Patients Experiencing at Least One Adverse Event (AE)
Time Frame: Baseline (Week 0) to end of the follow-up period
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Baseline (Week 0) to end of the follow-up period
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Time Frame: Baseline (Week 0) to end of the follow-up period
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Baseline (Week 0) to end of the follow-up period
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
Time Frame: Baseline (Week 0) to end of the follow-up period
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Baseline (Week 0) to end of the follow-up period

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.

General Publications

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

April 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 13, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3820C00008

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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