Opioid-Induced Constipation (OIC)Phase 3NCT01336205

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

A Phase 3 study testing NKTR-118 in people with Opioid-Induced Constipation (OIC), run by AstraZeneca at 169 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 84 years
Conditions the study is for: Opioid-Induced Constipation (OIC)
What is being tested?: NKTR-118
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 844 participants
Where: 169 sitesUnited States
Study dates: Apr 2011to Dec 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

169 sites in 1 country.

City, postcode or hospital

169 sites in 1 country

United States169 sites

Research Site
Akron, Ohio
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Albuquerque, New Mexico
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Alpharetta, Georgia
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Anderson, South Carolina
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Arcadia, California
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Athens, Alabama
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Atlanta, Georgia
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Austin, Texas
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Baltimore, Maryland
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Beavercreek, Ohio
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Bellevue, Nebraska
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Birmingham, Alabama
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Bloomington, Illinois
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Boise, Idaho
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Boynton Beach, Florida
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Bradenton, Florida
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Brooksville, Florida
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Calamazoo, Michigan
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Centerville, Ohio
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Charleston, South Carolina
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Charlotte, North Carolina
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Chattanooga, Tennessee
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Chicago, Illinois
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Chiefland, Florida
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Chino, California
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Clarksville, Tennessee
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Clearwater, Florida
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Clifton, New Jersey
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Clinton, Utah
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Colorado Springs, Colorado
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Columbia, Maryland
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Columbus, Georgia
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Council Bluffs, Iowa
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Crystal River, Florida
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Dallas, Texas
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Daytona Beach, Florida
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DeBary, Florida
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Deerfield Beach, Florida
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Delray Beach, Florida
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Downingtown, Pennsylvania
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Edgewater, Florida
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Elkin, North Carolina
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Encino, California
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Eustis, Florida
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Evansville, Indiana
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Flat Rock, North Carolina
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Fort Myers, Florida
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Freehold, New Jersey
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Fremont, California
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Fremont, Nebraska
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Garden Grove, Arizona
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Garden Grove, California
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Goodyear, Arizona
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Great Neck, New York
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Greer, South Carolina
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Harrisburg, North Carolina
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Hartsdale, New York
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Henderson, Nevada
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Hollywood, Maryland
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Houston, Texas
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Huntington Park, California
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Huntsville, Alabama
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Hurst, Texas
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Indianapolis, Indiana
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Inverness, Florida
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Jackson, Florida
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Jackson, Tennessee
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Jacksonville, Florida
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Jenkintown, Pennsylvania
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Jonesboro, Arkansas
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Jupiter, Florida
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Kansas City, Kansas
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La Mesa, California
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Laguna Hills, California
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Lakewood, California
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Lansing, Kansas
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Largo, Florida
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Las Vegas, Nevada
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Lauderhill, Florida
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Lexington, Texas
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Lincoln, Nebraska
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Little Rock, Arkansas
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Long Beach, California
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Louisville, Kentucky
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Lumberton, New Jersey
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Marietta, Georgia
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Marshall, Texas
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
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Middleton, Wisconsin
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Milan, Tennessee
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Mobile, Alabama
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Mooresville, North Carolina
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Morganton, North Carolina
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Morrisville, North Carolina
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Myrtle Beach, South Carolina
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Naples, Florida
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New Orleans, Louisiana
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New Tazewell, Tennessee
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New York, New York
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Norristown, Pennsylvania
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North Little Rock, Arkansas
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North Massapequa, New York
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North Miami, Florida
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Ocala, Florida
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Oceanside, California
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Ogden, Utah
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Orange, California
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Orange City, Florida
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Orlando, Florida
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Overland Park, Kansas
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Oviedo, Florida
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Pasadena, California
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Pell City, Alabama
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Pembroke Pines, Florida
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pikesville, Maryland
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Pinellas Park, Florida
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Plantation, Florida
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Port Orange, Florida
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Port Saint Lucie, Florida
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Pottstown, Pennsylvania
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Reisterstown, Maryland
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Richmond, Virginia
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Riverside, California
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Saint Doral, Florida
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Salt Lake City, Utah
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San Antonio, Texas
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San Bernardino, California
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San Diego, California
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San Francisco, California
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Santa Ana, California
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Schaumburg, Illinois
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Sherwood, Arkansas
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Shreveport, Louisiana
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South Miami, Florida
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Springfield, Virginia
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St Louis, Missouri
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St. George, Utah
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St. Petersburg, Florida
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Stamford, Connecticut
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Sugarland, Texas
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Suwanee, Georgia
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Tamarac, Florida
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Tampa, Florida
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Toledo, Ohio
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Toms River, New Jersey
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Traverse City, Michigan
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Tucker, Georgia
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Tucson, Arizona
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Tuscon, Arizona
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Victoria, Texas
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Virginia Beach, Virginia
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Voorhees Township, New Jersey
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Walnut Creek, California
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Watertown, Massachusetts
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West Jordan, Utah
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West Palm, Florida
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West Palm Beach, Florida
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Whittier, California
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Wichita, Kansas
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Willingboro, New Jersey
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Winston-Salem, North Carolina
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Winter Park, Florida

Other trials in United States

About this study

Official title: 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.

Conditions: Opioid-Induced Constipation (OIC)
Being tested: NKTR-118, Usual care
Keywords: Non-Cancer-Related Pain, Opioid-Induced Constipation
Medical subject headings: Opioid-Induced Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NKTR-118Drug
25 mg oral tablet once daily
Usual careDrug
As prescribed by the investigator

Study groups in NCT01336205
Study group	Role	What they receive
1	Experimental	Oral Treatment Receives: Drug: NKTR-118
2	Active comparator	Oral treatment Receives: Drug: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2012

First posted15 Apr 2011 (estimated)
Study startApr 2011
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid-Induced Constipation (OIC)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 844 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01336205
Sponsor's protocol ID: D3820C00008
Status last verified: Oct 2014
First submitted: 14 Apr 2011
Last updated: 20 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Webster L, Chey WD, Tack J, Lappalainen J, Diva U, Sostek M. Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther. 2014 Oct;40(7):771-9. doi: 10.1111/apt.12899. Epub 2014 Aug 12.
PubMed 25112584

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Constipation, Opioid-Induced
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
RecruitingPhase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
Not yet recruitingPhase 3
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
OIC
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)

All Opioid-Induced Constipation (OIC) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01336205
Acronym / sponsor ID: D3820C00008
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain, Opioid-Induced Constipation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 844 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 15 Apr 2011 (estimated)
Results: Posted 20 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: NKTR-118Oral Treatment
2	Active comparator	Drug: Usual careOral treatment

Who may qualify

Ages: 18 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NKTR-11825 mg oral tablet once daily	Drug	1
Usual careAs prescribed by the investigator	Drug	2

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 20 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NKTR-118 25 mg	563	330
Usual Care	281	192

Primary outcome: Incidence of Patients Experiencing at Least One Adverse Event (AE)

Time frame: Baseline (Week 0) to end of the follow-up period. Number. Unit: Participants

Measure	NKTR-118 25 mg n = 534	Usual Care n = 270
Value	437	195

Population analysed: The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.

Primary outcome: 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. Number. Unit: Participants

Measure	NKTR-118 25 mg n = 534	Usual Care n = 270
Value	56	NA

Primary outcome: Incidence of Patients Experiencing Severe Adverse Events (SAEs)

Time frame: Baseline (Week 0) to end of the follow-up period. Number. Unit: Participants

Measure	NKTR-118 25 mg n = 534	Usual Care n = 270
Value	51	30

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NKTR-118 25 mg	51 of 534 (9.6%)	365 of 534 (68.4%)	Not reported
Usual Care	30 of 270 (11.1%)	152 of 270 (56.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25112584Webster L, Chey WD, Tack J, Lappalainen J, Diva U, Sostek M. Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther. 2014 Oct;40(7):771-9. doi: 10.1111/apt.12899. Epub 2014 Aug 12.
Clinical\_Study\_Report\_Synopsis\_D3820C00008Link provided by the sponsor.

Related trials for Opioid-Induced Constipation (OIC)

RecruitingPhase 4
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
Constipation, Opioid-Induced
RecruitingObservational study
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
Opioid-induced Constipation
RecruitingPhase 1/2
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
Opioid-Induced Constipation (OIC)
Not yet recruitingPhase 3
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
OIC
RecruitingObservational study
Naldemedine in Clinical Practice in Cancer Patients With Opioid Induced CONstipation: Clinical Outcomes and Patient Experience
Cancer, Opioid Induced Constipation (OIC)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Sostek study director

AstraZeneca

169 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NKTR-118 in people with Opioid-Induced Constipation (OIC), run by AstraZeneca at 169 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Patients Experiencing at Least One Adverse Event (AE) (time frame: Baseline (Week 0) to end of the follow-up period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01336205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.