Opioid-Induced ConstipationPhase 3NCT01384292

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

A Phase 3 study testing NKTR-118 in people with Opioid-Induced Constipation, run by AstraZeneca at 140 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-Induced Constipation
What is being tested?: NKTR-118
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 140 sitesin 14 countries
Study dates: Jun 2011to Sep 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 years and older
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.
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.

Who cannot join

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.

Trial locations and contacts

140 sites in 14 countries.

Country

City, postcode or hospital

140 sites in 14 countries

United States81 sites

Research Site
Akron, Ohio
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Albany, Georgia
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Anderson, Indiana
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Aurora, Colorado
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Baypines, Florida
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Beaumont, Texas
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Beavercreek, Ohio
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Bellaire, Texas
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Bismarck, North Dakota
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Boston, Massachusetts
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Boynton Beach, Florida
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Casa Grande, Arizona
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Celebration, Florida
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Chattanooga, Tennessee
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Chicago, Illinois
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Clearwater, Florida
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Cleveland, Ohio
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Coral Gables, Florida
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Corpus Christi, Texas
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Dallas, Texas
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Danville, Pennsylvania
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Denver, Colorado
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Detroit, Michigan
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East Providence, Rhode Island
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Elkridge, Maryland
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Encino, California
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Evansville, Indiana
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Fairfax, Virginia
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Fairhaven, Massachusetts
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Flat Rock, North Carolina
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Fort Smith, Arkansas
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Fountain Valley, California
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Gilroy, California
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Great Neck, New York
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Hialeah, Florida
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Hollywood, Maryland
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Honolulu, Hawaii
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Hot Springs, Arkansas
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Houston, Texas
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Huntsville, Alabama
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Jacksonville, Florida
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Jefferson City, Missouri
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Kalamazoo, Michigan
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Lafayette, Louisiana
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Laguna Hills, California
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Lake Worth, Florida
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Lakeland, Florida
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Las Vegas, Nevada
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Lubbock, Texas
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Marietta, Georgia
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Miami, Florida
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Miami Lakes, Florida
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Middleton, Ohio
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Missoula, Montana
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Montebello, California
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Morrisville, North Carolina
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Naples, Florida
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North Little Rock, Arkansas
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Omaha, Nebraska
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Orange, California
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Owensboro, Kentucky
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Phoenix, Arizona
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Plantation, Florida
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Riverdale, Georgia
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Riverside, California
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Roswell, Georgia
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San Antonio, Texas
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San Bernardino, California
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Southaven, Mississippi
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Springfield, Illinois
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St Louis, Missouri
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Sugarland, Texas
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Syracuse, New York
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Tavares, Florida
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Toms River, New Jersey
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Tucson, Arizona
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Voorhees Township, New Jersey
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Wilmington, North Carolina
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Winston-Salem, North Carolina

Other trials in United States

Romania8 sites

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Baia Mare
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Brăila
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Brasov
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Bucharest
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Cluj-Napoca
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Craiova, Dolj
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Onești
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Ploieşti, Prahova

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Poland7 sites

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Brzozów
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Bydgoszcz
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Gdansk
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Gliwice
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Poznan
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Warsaw
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Wroclaw

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South Africa7 sites

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Benoni, Gauteng
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Bloemfontein, Free State
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Durban, Kz-natal
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Goodwood, W Cape
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Port Elizabeth, Eastern Cape
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Pretoria, Gauteng
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Vereeniging, Gauteng

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Bulgaria6 sites

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Haskovo
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Pleven
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Rousse
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Shumen
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Sofia
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Varna

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United Kingdom6 sites

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Chippenham, Wilts
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Coventry
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Guildford, Surrey
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London
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Norwich, Norfolk
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Penarth, CRF

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Australia5 sites

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Broadmeadow, New South Wales
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Frankston, Victoria
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Fremantle, Western Australia
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Malvern, Victoria
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Parkville, Victoria

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Belgium4 sites

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Brussels
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Edegem, Belgium
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Mons, Belgium
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Wetteren

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Germany4 sites

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Berlin, State of Berlin
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Hamburg, Free and Hanseatic City of Hamburg
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Offenbach
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Wiesbaden, Hesse

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Slovakia4 sites

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Bardejov
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Bratislava
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Košice
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Prešov

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Czechia3 sites

Research Site
Benešov
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České Budějovice
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Prague

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Spain3 sites

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A Coruña, Galicia
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Seville, Andalusia
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Valencia, Valencia

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Croatia1 site

Research Site
Zagreb

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Puerto Rico1 site

Research Site
Ponce

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About this study

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

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).

Conditions: Opioid-Induced Constipation
Being tested: NKTR-118, Placebo
Keywords: Cancer-Related Pain, Opioid-Induced Constipation, OIC
Medical subject headings: Opioid-Induced Constipation, Cancer Pain

What participants receive

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

NKTR-118Drug
12.5 mg oral tablet once daily
NKTR-118Drug
25 mg oral tablet once daily
PlaceboDrug
Oral treatment

Study groups in NCT01384292
Study group	Role	What they receive
1 (part A and B)	Experimental	Oral treatment Receives: Drug: NKTR-118
2 (part A and B)	Experimental	Oral treatment Receives: Drug: NKTR-118
3 (part A only)	Placebo comparator	Oral treatment Receives: Drug: Placebo

What is being measured

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

Response (Responder/Non-responder) to Study Drug
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.
Measured: Baseline to Week 4

Timeline

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

Jun 2011Sep 2012

First posted29 Jun 2011 (estimated)
Study startJun 2011
Primary completionSep 2012
Study completionSep 2012

Why it stopped: The study was stopped early due to recruitment challenges

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.
Other trials for Opioid-Induced ConstipationStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01384292
Sponsor's protocol ID: D3820C00006
Other IDs: 2011-001985-16
Status last verified: May 2015
First submitted: 28 Jun 2011
Last updated: 1 Jun 2015
Results posted: Yes, on ClinicalTrials.gov

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 trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01384292
Acronym / sponsor ID: D3820C00006
Conditions: Opioid-Induced Constipation
Keywords: Cancer-Related Pain, Opioid-Induced Constipation, OIC
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped early due to recruitment challenges
Enrolment: 14 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 29 Jun 2011 (estimated)
Results: Posted 1 Jun 2015

Clinical summary

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1 (part A and B)	Experimental	Drug: NKTR-118Oral treatment
2 (part A and B)	Experimental	Drug: NKTR-118Oral treatment
3 (part A only)	Placebo comparator	Drug: PlaceboOral treatment

Who may qualify

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

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

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-11812.5 mg oral tablet once daily	Drug	1 (part A and B)
NKTR-11825 mg oral tablet once daily	Drug	2 (part A and B)
PlaceboOral treatment	Drug	3 (part A only)

Primary outcome

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.

Results and safety

Results posted to the registry on 1 Jun 2015, 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 12.5 mg	5	5
NKTR-118 25 mg	5	5
Placebo	4	4

Primary outcome: Response (Responder/Non-responder) to Study Drug

Time frame: Baseline to Week 4. Number. Unit: Participants

Measure	NKTR-118 12.5 mg n = 5	NKTR-118 25 mg n = 5	Placebo n = 4
Value	4	3	2

Population analysed: All randomized patients

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NKTR-118 12.5 mg - Part A	0 of 5 (0%)	4 of 5 (80%)	Not reported
NKTR-118 25 mg - Part A	0 of 5 (0%)	3 of 5 (60%)	Not reported
Placebo - Part A	0 of 4 (0%)	3 of 4 (75%)	Not reported
NKTR-118 12.5 mg - Part B	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
NKTR-118 25 mg - Part B	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Limitations and caveats (from the sponsor): Due to recruitment challenges, enrollment was stopped early. 14 patients were randomized (\<5% of planned number), thus, there was insufficient data to perform the protocol-specified statistical analyses. Secondary outcome measures are not reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical\_Study\_Report\_Synopsis\_D3820C00006Link provided by the sponsor.

Related trials for Opioid-Induced Constipation

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.

The record lists no contact. Use the official record to reach the sponsor.

140 sites in 14 countries: 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, run by AstraZeneca at 140 sites in 14 countries.

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 5 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: stopped early, as of the sponsor's last update on 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Romania, Poland, South Africa, Bulgaria and 9 more countries. 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. Some participants in this study may receive a placebo. 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 1 Jun 2015). 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?

Response (Responder/Non-responder) to Study Drug (time frame: Baseline to Week 4). 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 NCT01384292.

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 1 Jun 2015.