A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Response to study drug, defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.
Response (responder/non-responder) to study drug, where a responder is defined as having at least 3 Rescue-free bowel movements (RFBMs) per week during the 4-week treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks.
Will be collected daily through the 4-week treatment period.
No
United States: Food and Drug Administration
D3820C00006
NCT01384292
June 2011
September 2012
Name | Location |
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Research Site | Alabaster, Alabama |
Research Site | Mesa, Arizona |
Research Site | Bentonville, Arkansas |
Research Site | Anaheim, California |
Research Site | Boulder, Colorado |
Research Site | Boca Raton, Florida |
Research Site | Albany, Georgia |
Research Site | Honolulu, Hawaii |
Research Site | Arlington Heights, Illinois |
Research Site | Bloomington, Indiana |
Research Site | Ashland, Kentucky |
Research Site | Baton Rouge, Louisiana |
Research Site | Baltimore, Maryland |
Research Site | Beverly, Massachusetts |
Research Site | Battle Kreek, Michigan |
Research Site | Hattiesburg, Mississippi |
Research Site | Branson, Missouri |
Research Site | Billings, Montana |
Research Site | Grand Island, Nebraska |
Research Site | Las Vegas, Nevada |
Research Site | Belleville, New Jersey |
Research Site | Albany, New York |
Research Site | Asheville, North Carolina |
Research Site | Bismarck, North Dakota |
Research Site | Akron, Ohio |
Research Site | Allentown, Pennsylvania |
Research Site | Pawtucket, Rhode Island |
Research Site | Charleston, South Carolina |
Research Site | Chattanooga, Tennessee |
Research Site | Abilene, Texas |
Research Site | Abington, Virginia |