A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
- Registration Number
- NCT00600119
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A placebo Placebo B NKTR-118 NKTR-118
- Primary Outcome Measures
Name Time Method Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in SBMs/Week Across the 28-day Double-blind Period 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.
Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire Days 1 through 28 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.
Change From Baseline in Patient Assessment of Constipation-Symptoms (PAC-SYM) Questionnaire Days 1 through 28 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.
Trial Locations
- Locations (33)
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
Pain & Rehabilitation Clinic of Chicago
🇺🇸Chicago, Illinois, United States
San Diego Managed Care Group
🇺🇸San Diego, California, United States
Riverhills Healthcare Research Division
🇺🇸Cincinnati, Ohio, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
PMI Health Research Group
🇺🇸Atlanta, Georgia, United States
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
Deerfoot Internal Medicine
🇺🇸Pinson, Alabama, United States
Tennessee Valley Pain Consultants / Center for Pain Management
🇺🇸Huntsville, Alabama, United States
Therapeutic Research Institute of Orange County
🇺🇸Laguna Hills, California, United States
Osler Medical, Inc. / Osler Clinical Research
🇺🇸Melbourne, Florida, United States
Millennium Pain Center
🇺🇸Bloomington, Illinois, United States
Gulf Coast Reserach
🇺🇸Baton Rouge, Louisiana, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Lovelace Scientific Resources, Inc.
🇺🇸Albuquerque, New Mexico, United States
Midwest Pharmaceutical Research, Inc.
🇺🇸St. Peters, Missouri, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
The Center for Clinical Research, LLC
🇺🇸Winston Salem, North Carolina, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Anderson Gastroenterology Associates, LLC
🇺🇸Anderson, South Carolina, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Gold Coast Research LLC
🇺🇸Weston, Florida, United States
Southeast Clinical Research
🇺🇸Chiefland, Florida, United States
MAPS Applied Research Center
🇺🇸Edina, Minnesota, United States
Pain Treatment Center of the Bluegrass
🇺🇸Lexington, Kentucky, United States
Arapahoe Gastroenterology, PC
🇺🇸Littleton, Colorado, United States
Four Seasons Hospice and Palliative Care
🇺🇸Flat Rock, North Carolina, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
Options Health Research
🇺🇸Tulsa, Oklahoma, United States
Medford Medical Clinic
🇺🇸Medford, Oregon, United States
Spokane Internal Medicine
🇺🇸Spokane, Washington, United States
Singleton Health Center
🇺🇸Orangeburg, South Carolina, United States