A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
NCT ID: NCT00600119
Last Updated: 2015-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
207 participants
INTERVENTIONAL
2007-12-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Placebo
placebo
placebo, oral, once daily (QD)
B
NKTR-118
NKTR-118
5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
Interventions
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placebo
placebo, oral, once daily (QD)
NKTR-118
5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Sostek
Role: STUDY_DIRECTOR
AstraZeneca Pharmaceuticals, Wilm DE
Locations
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Tennessee Valley Pain Consultants / Center for Pain Management
Huntsville, Alabama, United States
Deerfoot Internal Medicine
Pinson, Alabama, United States
Genova Clinical Research, Inc.
Tucson, Arizona, United States
Therapeutic Research Institute of Orange County
Laguna Hills, California, United States
San Diego Managed Care Group
San Diego, California, United States
Arapahoe Gastroenterology, PC
Littleton, Colorado, United States
Southeast Clinical Research
Chiefland, Florida, United States
Osler Medical, Inc. / Osler Clinical Research
Melbourne, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Gold Coast Research LLC
Weston, Florida, United States
PMI Health Research Group
Atlanta, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Millennium Pain Center
Bloomington, Illinois, United States
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, United States
Pain Treatment Center of the Bluegrass
Lexington, Kentucky, United States
Gulf Coast Reserach
Baton Rouge, Louisiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
MAPS Applied Research Center
Edina, Minnesota, United States
Midwest Pharmaceutical Research, Inc.
City of Saint Peters, Missouri, United States
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
Four Seasons Hospice and Palliative Care
Flat Rock, North Carolina, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Riverhills Healthcare Research Division
Cincinnati, Ohio, United States
Options Health Research
Tulsa, Oklahoma, United States
Medford Medical Clinic
Medford, Oregon, United States
Anderson Gastroenterology Associates, LLC
Anderson, South Carolina, United States
Singleton Health Center
Orangeburg, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Spokane Internal Medicine
Spokane, Washington, United States
Countries
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Related Links
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Other Identifiers
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07-IN-NX003
Identifier Type: -
Identifier Source: org_study_id
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