Spots Global Cancer Trial Database for Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
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Trial Identification
Brief Title: Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
Official Title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
Study ID: NCT02270983
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Forest Investigative Site 002, Anniston, Alabama, United States
Forest Investigative Site 001, Foley, Alabama, United States
Forest Investigative Site 007, Phoenix, Arizona, United States
Forest Investigative Site 008, Tucson, Arizona, United States
Forest Investigative Site 003, North Little Rock, Arkansas, United States
Forest Investigative Site 018, Anaheim, California, United States
Forest Investigative Site 014, Fountain Valley, California, United States
Forest Investigative Site 019, Fresno, California, United States
Forest Investigative Site 017, Garden Grove, California, United States
Forest Investigative Site 010, Gold River, California, United States
Forest Investigative Site 009, Lincoln, California, United States
Forest Investigative Site 012, North Hollywood, California, United States
Forest Investigative Site 011, Orange, California, United States
Forest Investigative Site 016, Sacramento, California, United States
Forest Investigative Site 013, San Diego, California, United States
Forest Investigative Site 015, Santa Ana, California, United States
Forest Investigative Site 020, Colorado Springs, Colorado, United States
Forest Investigative Site 021, Bristol, Connecticut, United States
Forest Investigative Site 035, Boynton Beach, Florida, United States
Forest Investigative Site 038, Bradenton, Florida, United States
Forest Investigative Site 024, DeLand, Florida, United States
Forest Investigative Site 027, Gainesville, Florida, United States
Forest Investigative Site 023, Jacksonville, Florida, United States
Forest Investigative Site 036, Jupiter, Florida, United States
Forest Investigative Site 037, Lauderdale Lakes, Florida, United States
Forest Investigative Site 028, Miami, Florida, United States
Forest Investigative Site 040, Orlando, Florida, United States
Forest Investigative Site 022, Oviedo, Florida, United States
Forest Investigative Site 034, Port Orange, Florida, United States
Forest Investigative Site 029, Seminole, Florida, United States
Forest Investigative Site 031, Tampa, Florida, United States
Forest Investigative Site 033, Tampa, Florida, United States
Forest Investigative Site 030, Tampa, Florida, United States
Forest Investigative Site 039, West Palm Beach, Florida, United States
Forest Investigative Site 032, Weston, Florida, United States
Forest Investigative Site 041, Marietta, Georgia, United States
Forest Investigative Site 042, Woodstock, Georgia, United States
Forest Investigative Site 043, Chicago, Illinois, United States
Forest Investigative Site 044, Evansville, Indiana, United States
Forest Investigative Site 045, Madisonville, Kentucky, United States
Forest Investigative Site 046, Metairie, Louisiana, United States
Forest Investigative Site 048, Hagerstown, Maryland, United States
Forest Investigative Site 047, Watertown, Massachusetts, United States
Forest Investigative Site 050, Chesterfield, Michigan, United States
Forest Investigative Site 049, Flint, Michigan, United States
Forest Investigative Site 058, Omaha, Nebraska, United States
Forest Investigative Site 057, Omaha, Nebraska, United States
Forest Investigative Site 059, Williamsville, New York, United States
Forest Investigative Site 082, Asheboro, North Carolina, United States
Forest Investigative Site 054, Chapel Hill, North Carolina, United States
Forest Investigative Site 088, Davidson, North Carolina, United States
Forest Investigative Site 051, Flat Rock, North Carolina, United States
Forest Investigative Site 052, Greensboro, North Carolina, United States
Forest Investigative Site 055, Greensboro, North Carolina, United States
Forest Investigative Site 053, Winston-Salem, North Carolina, United States
Forest Investigative Site 056, Fargo, North Dakota, United States
Forest Investigative Site 062, Cincinnati, Ohio, United States
Forest Investigative Site 061, Columbus, Ohio, United States
Forest Investigative Site 060, Mentor, Ohio, United States
Forest Investigative Site 087, Wadsworth, Ohio, United States
Forest Investigative Site 064, Oklahoma City, Oklahoma, United States
Forest Investigative Site 063, Oklahoma City, Oklahoma, United States
Forest Investigative Site 065, Tulsa, Oklahoma, United States
Forest Investigative Site 066, Medford, Oregon, United States
Forest Investigative Site 067, Levittown, Pennsylvania, United States
Forest Investigative Site 080, Philadelphia, Pennsylvania, United States
Forest Investigative Site 068, Cumberland, Rhode Island, United States
Forest Investigative Site 070, Charleston, South Carolina, United States
Forest Investigative Site 083, Richardson, Texas, United States
Forest Investigative Site 074, San Antonio, Texas, United States
Forest Investigative Site 073, San Antonio, Texas, United States
Forest Investigative Site 071, San Antonio, Texas, United States
Forest Investigative Site 075, Logan, Utah, United States
Forest Investigative Site 084, Ogden, Utah, United States
Forest Investigative Site 076, West Jordan, Utah, United States
Forest Investigative Site 078, Christiansburg, Virginia, United States
Forest Investigative Site 079, Bellevue, Washington, United States
Contact Details
Name: Patricia D'Astoli, RN
Affiliation: Forest Laboratories, LLC, an Allergan Affiliate
Role: STUDY_DIRECTOR
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