A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

January 9, 2017 updated by: AstraZeneca

A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.

Study Overview

Status

Status

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

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.
302

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
      • Darlinghurst, New South Wales, Australia
        • Research Site
      • Port Kembla, New South Wales, Australia
        • Research Site
      • Westmead, New South Wales, Australia
        • Research Site
    • Queensland
      • Greenslopes, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
    • Western Australia
      • Fremantle, Western Australia, Australia
        • Research Site
      • Nedlands, Western Australia, Australia
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
    • BR
      • Potsdam, BR, Germany
        • Research Site
    • HE
      • Dietzenbach, HE, Germany
        • Research Site
      • Huttenberg, HE, Germany
        • Research Site
      • Wetzlar, HE, Germany
        • Research Site
    • HH
      • Hamburg, HH, Germany
        • Research Site
    • MV
      • Schwerin, MV, Germany
        • Research Site
    • NI
      • Celle, NI, Germany
        • Research Site
      • Hannover, NI, Germany
        • Research Site
    • NW
      • Essen, NW, Germany
        • Research Site
    • RP
      • Mainz, RP, Germany
        • Research Site
    • SH
      • Kiel, SH, Germany
        • Research Site
    • SN
      • Leipzig, SN, Germany
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Kosice, Slovakia
        • Research Site
      • Presov, Slovakia
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Calera, Alabama, United States
        • Research Site
    • Arizona
      • Glendale, Arizona, United States
        • Research Site
      • Mesa, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Research Site
      • Malvern, Arkansas, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Beverly Hills, California, United States
        • Research Site
      • Burbank, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • Laguana Hills, California, United States
        • Research Site
      • Laguna Hills, California, United States
        • Research Site
      • Long Beach, California, United States
        • Research Site
      • Los Gatos, California, United States
        • Research Site
      • Montebello, California, United States
        • Research Site
      • National City, California, United States
        • Research Site
      • Norwalk, California, United States
        • Research Site
      • Paramount, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Santa Ana, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States
        • Research Site
      • Brooksville, Florida, United States
        • Research Site
      • Crystal River, Florida, United States
        • Research Site
      • Deland, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Jupiter, Florida, United States
        • Research Site
      • Maitland, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Naples, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Ormond Beach, Florida, United States
        • Research Site
      • Pembroke Pines, Florida, United States
        • Research Site
      • Plantation, Florida, United States
        • Research Site
      • Tamarac, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Venice, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
      • Winter Park, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Decatur, Georgia, United States
        • Research Site
    • Idaho
      • Boise, Idaho, United States
        • Research Site
    • Illinois
      • Bloomington, Illinois, United States
        • Research Site
      • Rockford, Illinois, United States
        • Research Site
    • Indiana
      • Avon, Indiana, United States
        • Research Site
      • Evansville, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Reserach Site
    • Iowa
      • West Des Moines, Iowa, United States
        • Research Site
    • Maryland
      • Pikesville, Maryland, United States
        • Research Site
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
    • Mississippi
      • Biloxi, Mississippi, United States
        • Research Site
    • Missouri
      • St Joseph, 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
      • Trenton, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
      • Hickory, North Carolina, United States
        • Research Site
      • High Point, North Carolina, United States
        • Research Site
      • Morrisville, North Carolina, United States
        • Research Site
    • Ohio
      • Beavercreek, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
    • Oregon
      • Medord, Oregon, United States
        • Research Site
    • Pennsylvania
      • Feasterville, Pennsylvania, United States
        • Research Site
      • Huntingdon Valley, Pennsylvania, United States
        • Research Site
      • Levittown, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Yardley, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Cumberland, Rhode Island, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
      • Greer, South Carolina, United States
        • Research Site
      • Orangeburg, South Carolina, United States
        • Research Site
    • Tennessee
      • Clarksville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Doral, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • North Richland Hills, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Washington
      • Spokane, Washington, 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 to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have completed the 12-week study D3820C00004 through Visit 8.
  • Provision of written informed consent prior to any study-specific procedures.
  • Men and women who were between the ages of >18 and <85 years at the time of the screening visit for study D3820C00004.
  • Continuing to receive a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies.
  • Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (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 the screening visit of study D3820C00004 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 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: 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.
Placebo Comparator: Placebo
Drug: Placebo
Oral tablet intake once daily
Experimental: NKTR-118 12.5mg
Drug: NKTR-118
25 mg oral tablet once daily
Drug: NKTR-118
12.5 mg oral tablet once daily
Experimental: NKTR-118 25mg
Drug: NKTR-118
25 mg oral tablet once daily
Drug: NKTR-118
12.5 mg oral tablet once daily

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
Incidence of Patients Experiencing at Least One Adverse Event (AE)
Time Frame: Baseline (Week 0) to end of the follow-up period (Week 14)
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 (Week 14)
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 (Week 14)
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 (Week 14)
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
Time Frame: Baseline (Week 0) to end of the follow-up period (Week 14)
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 (Week 14)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Time Frame: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Time Frame: Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)

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.

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

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.
July 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.
July 14, 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.
July 15, 2011

Study Record Updates

Last Update Posted (Actual)

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.
February 23, 2017

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.
January 9, 2017

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.
January 1, 2017

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.
  • D3820C00007

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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