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)
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Opioid Induced Constipation (OIC)
Both
Opioid Induced Constipation (OIC)
Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Increase in number of spontaneous bowel movements from baseline
Outcome Time Frame:
5 weeks
Safety Issue:
No
Principal Investigator
Mark Sostek
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca Pharmaceuticals, Wilm DE
Authority:
United States: Food and Drug Administration
Study ID:
07-IN-NX003
NCT ID:
NCT00600119
Start Date:
December 2007
Completion Date:
April 2009
Related Keywords:
- Opioid Induced Constipation (OIC)
- NKTR, constipation, opioid, induced, bowel, dysfunction, Naloxol, Naloxone, Narcan, PEG naloxol, OIC, OBD, Nektar
- Constipation
Name | Location |
|---|---|
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Palm Beach Research Center | West Palm Beach, Florida 33409 |
| Lifetree Clinical Research | Salt Lake City, Utah 84106 |
| The Center for Clinical Research, LLC | Winston-Salem, North Carolina 27103 |
| Investigative Clinical Research of Indiana, LLC | Indianapolis, Indiana 46254 |
| Millennium Pain Center | Bloomington, Illinois 61701 |
| Options Health Research | Tulsa, Oklahoma 74104 |
| Anderson Gastroenterology Associates, LLC | Anderson, South Carolina 39621 |
| Therapeutic Research Institute of Orange County | Laguna Hills, California 92653 |
| Tennessee Valley Pain Consultants / Center for Pain Management | Huntsville, Alabama 35801 |
| Deerfoot Internal Medicine | Pinson, Alabama 35126 |
| Genova Clinical Research, Inc. | Tucson, Arizona 85741 |
| San Diego Managed Care Group | San Diego, California 92128 |
| Arapahoe Gastroenterology, PC | Littleton, Colorado 80120 |
| Southeast Clinical Research | Chiefland, Florida 32626 |
| Osler Medical, Inc. / Osler Clinical Research | Melbourne, Florida 32901 |
| Gold Coast Research LLC | Weston, Florida 33324 |
| PMI Health Research Group | Atlanta, Georgia 30312 |
| Northwest Clinical Trials | Boise, Idaho 83704 |
| Pain & Rehabilitation Clinic of Chicago | Chicago, Illinois 60610 |
| Pain Treatment Center of the Bluegrass | Lexington, Kentucky 40503 |
| Gulf Coast Reserach | Baton Rouge, Louisiana 70808 |
| Centennial Medical Group | Elkridge, Maryland 21075 |
| MAPS Applied Research Center | Edina, Minnesota 55435 |
| Midwest Pharmaceutical Research, Inc. | St. Peters, Missouri 63376 |
| Lovelace Scientific Resources, Inc. | Albuquerque, New Mexico 87108 |
| Long Island Gastrointestinal Research Group | Great Neck, New York 11023 |
| Four Seasons Hospice and Palliative Care | Flat Rock, North Carolina 28731 |
| Riverhills Healthcare Research Division | Cincinnati, Ohio 45219 |
| Medford Medical Clinic | Medford, Oregon 97504 |
| Singleton Health Center | Orangeburg, South Carolina 29118 |
| ClinSearch, LLC | Chattanooga, Tennessee 37421 |
| Spokane Internal Medicine | Spokane, Washington 99216 |
