A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
May 28, 2015 updated by: AstraZeneca
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Dose Escalation Study to Evaluate the Efficacy, Safety and Tolerability of NKTR-118 in Patients With Opioid-Induced Constipation (OIC)
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial.
It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD).
The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
207
Phase
- Phase 2
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
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Alabama
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Huntsville, Alabama, United States, 35801
- Tennessee Valley Pain Consultants / Center for Pain Management
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Pinson, Alabama, United States, 35126
- Deerfoot Internal Medicine
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Arizona
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Tucson, Arizona, United States, 85741
- Genova Clinical Research, Inc.
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California
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Laguna Hills, California, United States, 92653
- Therapeutic Research Institute of Orange County
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San Diego, California, United States, 92128
- San Diego Managed Care Group
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Colorado
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Littleton, Colorado, United States, 80120
- Arapahoe Gastroenterology, PC
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Florida
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Chiefland, Florida, United States, 32626
- Southeast Clinical Research
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Melbourne, Florida, United States, 32901
- Osler Medical, Inc. / Osler Clinical Research
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West Palm Beach, Florida, United States, 33409
- Palm Beach Research Center
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Weston, Florida, United States, 33324
- Gold Coast Research LLC
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Georgia
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Atlanta, Georgia, United States, 30312
- PMI Health Research Group
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Idaho
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Boise, Idaho, United States, 83704
- Northwest Clinical Trials
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Illinois
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Bloomington, Illinois, United States, 61701
- Millennium Pain Center
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Chicago, Illinois, United States, 60610
- Pain & Rehabilitation Clinic of Chicago
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Indiana
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Indianapolis, Indiana, United States, 46254
- Investigative Clinical Research of Indiana, LLC
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Kentucky
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Lexington, Kentucky, United States, 40503
- Pain Treatment Center of the Bluegrass
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Gulf Coast Reserach
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Maryland
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Elkridge, Maryland, United States, 21075
- Centennial Medical Group
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Minnesota
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Edina, Minnesota, United States, 55435
- MAPS Applied Research Center
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Missouri
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St. Peters, Missouri, United States, 63376
- Midwest Pharmaceutical Research, Inc.
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- Lovelace Scientific Resources, Inc.
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New York
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Great Neck, New York, United States, 11023
- Long Island Gastrointestinal Research Group
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North Carolina
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Flat Rock, North Carolina, United States, 28731
- Four Seasons Hospice and Palliative Care
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Winston Salem, North Carolina, United States, 27103
- The Center for Clinical Research, LLC
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Cincinnati, Ohio, United States, 45219
- Riverhills Healthcare Research Division
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Oklahoma
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Tulsa, Oklahoma, United States, 74104
- Options Health Research
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Oregon
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Medford, Oregon, United States, 97504
- Medford Medical Clinic
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South Carolina
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Anderson, South Carolina, United States, 29621
- Anderson Gastroenterology Associates, LLC
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Orangeburg, South Carolina, United States, 29118
- Singleton Health Center
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Tennessee
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Chattanooga, Tennessee, United States, 37421
- ClinSearch, LLC
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Utah
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Salt Lake City, Utah, United States, 84106
- Lifetree Clinical Research
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Washington
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Spokane, Washington, United States, 99216
- Spokane Internal Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- 18 years of age or older, male or female
- Receiving a stable opioid regimen
- Documented opioid-induced constipation
- Willingness to stop all laxatives and other bowel regimens. The use of constipation rescue medication will be allowed during the study.
Main Exclusion Criteria:
- Life expectancy less than 6 months
- Active substance abuse
- Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea or intermittent loose stools or constipation
- Pregnant or breast-feeding
- Any receipt of an investigational medication within 30 days of screening
- History or presence of specific cardiac, neurologic, endocrine and/or psychiatric conditions
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: A
Placebo
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placebo, oral, once daily (QD)
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Experimental: B
NKTR-118
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5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1
Time Frame: Days 1 through 7
|
Change from baseline in SBMs/week during Week 1 was defined as SBMs/week during the first week of double-blind study medication (between Visit 4 and Visit 6) minus baseline SBMs/week.
Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
An SBM was defined as a BM without the use of laxatives in the previous 24 hours as recorded in the e-diary.
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Days 1 through 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in SBMs/Week Across the 28-day Double-blind Period
Time Frame: Days 1 through 28
|
Change from baseline in SBMs/week across the 28-day double-blind period was calculated as SBMs/week during 28-day double-blind study treatment period minus baseline SBMs/week.
Baseline was defined as the average SBMs/week during the 2-week OIC screening period.
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Days 1 through 28
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Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire
Time Frame: Days 1 through 28
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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 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.
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Days 1 through 28
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Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire
Time Frame: Days 1 through 28
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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 is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item).
A negative change from baseline indicates improvement.
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Days 1 through 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
December 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
January 11, 2008
First Submitted That Met QC Criteria
January 11, 2008
First Posted (Estimate)
January 24, 2008
Study Record Updates
Last Update Posted (Estimate)
June 12, 2015
Last Update Submitted That Met QC Criteria
May 28, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-IN-NX003
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.