A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

Phase 2

Completed

• Conditions: Opioid Induced Constipation (OIC)
• Interventions: Drug: placebo; Drug: NKTR-118

• 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

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-24
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Disposition First Submitted: 2013-01-28
• Disposition First Submitted QC: 2013-01-28
• Disposition First Posted: 2013-01-29
• Results First Submitted: 2014-10-13
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-28
• Last Update Submitted: 2015-05-28
• Results First Posted: 2015-06-12
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

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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

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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