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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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