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
NCT ID: NCT02270983
Last Updated: 2019-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2014-10-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Linaclotide 145 micrograms
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Linaclotide 145 micrograms
Linaclotide 290 micrograms
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Linaclotide 290 micrograms
Placebo
Oral capsule, taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center after at least a 2-hour fast.
Placebo
Matching placebo
Interventions
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Linaclotide 145 micrograms
Linaclotide 290 micrograms
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks
* Patient meets protocol criteria for Opioid-Induced Constipation (OIC): \< 3 spontaneous bowel movements (SBMs) per week and reports one of the following symptoms for at least 4 weeks:
1. Straining during \> 25% of BMs
2. Lumpy or hard stools during \> 25% of BMs
3. Sensation of incomplete evacuation during \> 25% of BMs
* Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines
* Patient has successfully completed protocol procedures (with no clinically significant findings)
* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting
* Patient has a total of \< 6 SBMs in IVRS during the 14 days before and up to the time of Randomization
* Patient has adequate relief and well-controlled pain with current dose of opioid
Exclusion Criteria
* Patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment
* Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior to initiation of opioid treatment
* Patient has a history of loose or watery stools for \> 25% of BMs during the 3 months before the Screening in the absence of laxatives, suppositories, or enemas
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Patricia D'Astoli, RN
Role: STUDY_DIRECTOR
Forest Laboratories, LLC, an Allergan Affiliate
Locations
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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
Countries
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References
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Brenner DM, Argoff CE, Fox SM, Bochenek W, D'Astoli P, Blakesley RE, Reasner DS, O'Dea CR, Cash BD. Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study. Pain. 2020 May;161(5):1027-1036. doi: 10.1097/j.pain.0000000000001754.
Other Identifiers
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LIN-MD-40
Identifier Type: -
Identifier Source: org_study_id
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