A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Completed · Phase 2 · Has a placebo group
Conditions studied: Opioid Induced Constipation (OIC)
In brief
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.
Key facts
- Study ID
- NCT00600119
- Run by
- AstraZeneca
- People needed
- 207
- Starts
- 2007-12-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2015-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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