Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
NCT ID: NCT01642914
Last Updated: 2016-04-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
487 participants
INTERVENTIONAL
2012-08-31
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
NCT02291679
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
NCT00765882
Trial of Linaclotide in Patients With Chronic Constipation
NCT00730015
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
NCT00402337
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
NCT00765999
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Linaclotide 290 micrograms
Linaclotide 290 micrograms
Linaclotide 290 micrograms
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Linaclotide 145 Micrograms
Linaclotide 145 micrograms
Linaclotide 145 micrograms
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Placebo
Matching placebo
Matching placebo
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Linaclotide 290 micrograms
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Linaclotide 145 micrograms
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Matching placebo
oral capsule, taken once daily each morning at least 30 minutes before breakfast
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has successfully completed protocol procedures (with no clinically significant findings)
* Patient meets protocol criteria for Chronic Constipation(CC): \< 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks:
1. Straining during more than 25% of BMs
2. Lumpy or hard stools during more than 25% of BMs
3. Sensation of incomplete evacuation during more than 25% of BMs
* Patient demonstrates continued chronic constipation and bloating through Pretreatment Period
* Patient is compliant with Interactive voice response System (IVRS)
Exclusion Criteria
* Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
* 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
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ironwood Pharmaceuticals, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Shiff, MD
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Forest Investigative Site 020
Chandler, Arizona, United States
Forest Investigative Site 102
Chandler, Arizona, United States
Forest Investigative Site 149
Glendale, Arizona, United States
Forest Investigative Site 126
Goodyear, Arizona, United States
Forest Investigative Site 018
Phoenix, Arizona, United States
Forest Investigative Site 061
Phoenix, Arizona, United States
Forest Investigative Site 022
Scottsdale, Arizona, United States
Forest Investigative Site 079
Tucson, Arizona, United States
Forest Investigative Site 071
Tucson, Arizona, United States
Forest Investigative Site 135
North Little Rock, Arkansas, United States
Forest Investigative Site 106
Anaheim, California, United States
Forest Investigative Site 104
Laguna Hills, California, United States
Forest Investigative Site 066
Mission Hills, California, United States
Forest Investigative Site 095
San Carlos, California, United States
Forest Investigative Site 009
San Diego, California, United States
Forest Investigative Site 151
Santa Monica, California, United States
Forest Investigative Site 010
Westlake Village, California, United States
Forest Investigative Site 012
Boulder, Colorado, United States
Forest Investigative Site 041
Colorado Springs, Colorado, United States
Forest Investigative Site 045
Colorado Springs, Colorado, United States
Forest Investigative Site 060
Longmont, Colorado, United States
Forest Investigative Site 007
Bristol, Connecticut, United States
Forest Investigative Site 153
Waterbury, Connecticut, United States
Forest Investigative Site 091
Boynton Beach, Florida, United States
Forest Investigative Site 047
Bradenton, Florida, United States
Forest Investigative Site 042
Brooksville, Florida, United States
Forest Investigative Site 133
Coral Gables, Florida, United States
Forest Investigative Site 131
DeLand, Florida, United States
Forest Investigative Site 051
Fort Myers, Florida, United States
Forest Investigative Site 137
Inverness, Florida, United States
Forest Investigative Site 114
Jacksonville, Florida, United States
Forest Investigative Site 004
Jupiter, Florida, United States
Forest Investigative Site 016
Kissimmee, Florida, United States
Forest Investigative Site 097
Lauderdale Lakes, Florida, United States
Forest Investigative Site 003
Miami, Florida, United States
Forest Investigative Site 002
Miami, Florida, United States
Forest Investigative Site 130
New Smyrna Beach, Florida, United States
Forest Investigative Site 040
Ocala, Florida, United States
Forest Investigative Site 083
Orlando, Florida, United States
Forest Investigative Site 150
Oviedo, Florida, United States
Forest Investigative Site 132
Port Orange, Florida, United States
Forest Investigative Site 127
Seminole, Florida, United States
Forest Investigative Site 087
St. Petersburg, Florida, United States
Forest Investigative Site 064
Tampa, Florida, United States
Forest Investigative Site 115
Zephyrhills, Florida, United States
Forest Investigative Site 021
Marietta, Georgia, United States
Forest Investigative Site 011
Marietta, Georgia, United States
Forest Investigative Site 109
Sandy Springs, Georgia, United States
Forest Investigative Site 037
Stockbridge, Georgia, United States
Forest Investigative Site 023
Woodstock, Georgia, United States
Forest Investigative Site 015
Idaho Falls, Idaho, United States
Forest Investigative Site 122
Peoria, Illinois, United States
Forest Investigative Site 043
Rockford, Illinois, United States
Forest Investigative Site 107
Anderson, Indiana, United States
Forest Investigative Site 117
Clive, Iowa, United States
Forest Investigative Site 146
Clive, Iowa, United States
Forest Investigative Site 143
Davenport, Iowa, United States
Forest Investigative Site 055
Iowa City, Iowa, United States
Forest Investigative Site 028
Newton, Kansas, United States
Forest Investigative Site 112
Overland Park, Kansas, United States
Forest Investigative Site 034
Wichita, Kansas, United States
Forest Investigative Site 032
Wichita, Kansas, United States
Forest Investigative Site 128
Lexington, Kentucky, United States
Forest Investigative Site 134
Madisonville, Kentucky, United States
Forest Investigative Site 121
Baton Rouge, Louisiana, United States
Forest Investigative Site 124
Metairie, Louisiana, United States
Forest Investigative Site 101
Monroe, Louisiana, United States
Forest Investigative Site 058
Shreveport, Louisiana, United States
Forest Investigative Site 099
Shreveport, Louisiana, United States
Forest Investigative Site 062
Baltimore, Maryland, United States
Forest Investigative Site 008
Chevy Chase, Maryland, United States
Forest Investigative Site 014
Hagerstown, Maryland, United States
Forest Investigative Site 024
Towson, Maryland, United States
Forest Investigative Site 006
Boston, Massachusetts, United States
Forest Investigative Site 070
Chesterfield, Michigan, United States
Forest Investigative Site 145
Traverse City, Michigan, United States
Forest Investigative Site 141
Jackson, Mississippi, United States
Forest Investigative Site 077
Fremont, Nebraska, United States
Forest Investigative Site 048
Omaha, Nebraska, United States
Forest Investigative Site 052
Henderson, Nevada, United States
Forest Investigative Site 080
Las Vegas, Nevada, United States
Forest Investigative Site 036
Clifton, New Jersey, United States
Forest Investigative Site 088
Marlton, New Jersey, United States
Forest Investigative Site 033
Vineland, New Jersey, United States
Forest Investigative Site 063
Albuquerque, New Mexico, United States
Forest Investigative Site 093
Albuquerque, New Mexico, United States
Forest Investigative Site 044
Brooklyn, New York, United States
Forest Investigative Site 017
Great Neck, New York, United States
Forest Investigative Site 142
Asheboro, North Carolina, United States
Forest Investigative Site 094
Asheville, North Carolina, United States
Forest Investigative Site 075
Boone, North Carolina, United States
Forest Investigative Site 123
Chapel Hill, North Carolina, United States
Forest Investigative Site 140
Davidson, North Carolina, United States
Forest Investigative Site 039
Fayetteville, North Carolina, United States
Forest Investigative Site 031
Greensboro, North Carolina, United States
Forest Investigative Site 029
Greensboro, North Carolina, United States
Forest Investigative Site 078
Greensboro, North Carolina, United States
Forest Investigative Site 084
Harrisburg, North Carolina, United States
Forest Investigative Site 073
Hickory, North Carolina, United States
Forest Investigative Site 050
Hickory, North Carolina, United States
Forest Investigative Site 139
High Point, North Carolina, United States
Forest Investigative Site 027
Raleigh, North Carolina, United States
Forest Investigative Site 119
Statesville, North Carolina, United States
Forest Investigative Site 089
Wilmington, North Carolina, United States
Forest Investigative Site 074
Winston-Salem, North Carolina, United States
Forest Investigative Site 025
Cincinnati, Ohio, United States
Forest Investigative Site 120
Cincinnati, Ohio, United States
Forest Investigative Site 056
Cleveland, Ohio, United States
Forest Investigative Site 026
Columbus, Ohio, United States
Forest Investigative Site 098
Dayton, Ohio, United States
Forest Investigative Site 090
Dayton, Ohio, United States
Forest Investigative Site 085
Mentor, Ohio, United States
Forest Investigative Site 068
Wadsworth, Ohio, United States
Forest Investigative Site 118
Oklahoma City, Oklahoma, United States
Forest Investigative Site 081
Levittown, Pennsylvania, United States
Forest Investigative Site 001
Pittsburgh, Pennsylvania, United States
Forest Investigative Site 110
Reading, Pennsylvania, United States
Forest Investigative Site 116
Greer, South Carolina, United States
Forest Investigative Site 046
Simpsonville, South Carolina, United States
Forest Investigative Site 092
Dakota Dunes, South Dakota, United States
Forest Investigative Site 129
Chattanooga, Tennessee, United States
Forest Investigative Site 138
Kingsport, Tennessee, United States
Forest Investigative Site 125
Austin, Texas, United States
Forest Investigative Site 035
Dallas, Texas, United States
Forest Investigative Site 005
Dallas, Texas, United States
Forest Investigative Site 111
Fort Worth, Texas, United States
Forest Investigative Site 100
Houston, Texas, United States
Forest Investigative Site 067
Katy, Texas, United States
Forest Investigative Site 049
Pasadena, Texas, United States
Forest Investigative Site 030
San Antonio, Texas, United States
Forest Investigative Site 076
San Antonio, Texas, United States
Forest Investigative Site 065
Sugarland, Texas, United States
Forest Investigative Site 019
Ogden, Utah, United States
Forest Investigative Site 105
Salt Lake City, Utah, United States
Forest Investigative Site 113
Sandy City, Utah, United States
Forest Investigative Site 053
Charlottesville, Virginia, United States
Forest Investigative Site 108
Chesapeake, Virginia, United States
Forest Investigative Site 136
Chesapeake, Virginia, United States
Forest Investigative Site 148
Christiansburg, Virginia, United States
Forest Investigative Site 072
Lynchburg, Virginia, United States
Forest Investigative Site 069
Newport News, Virginia, United States
Forest Investigative Site 013
Norfolk, Virginia, United States
Forest Investigative Site 038
Richmond, Virginia, United States
Forest Investigative Site 103
Spokane, Washington, United States
Forest Investigative Site 082
La Crosse, Wisconsin, United States
Forest Investigative Site 096
Milwaukee, Wisconsin, United States
Forest Investigative Site 054
Greater Sudbury, Ontario, Canada
Forest Investigative Site 059
Sarnia, Ontario, Canada
Forest Investigative Site 086
Toronto, Ontario, Canada
Forest Investigative Site 147
Toronto, Ontario, Canada
Forest Investigative Site 152
Vaughan, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lacy BE, Shea EP, Manuel M, Abel JL, Jiang H, Taylor DCA. Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications. PLoS One. 2021 Jan 11;16(1):e0243318. doi: 10.1371/journal.pone.0243318. eCollection 2021.
Lacy BE, Schey R, Shiff SJ, Lavins BJ, Fox SM, Jia XD, Blakesley RE, Hao X, Cronin JA, Currie MG, Kurtz CB, Johnston JM, Lembo AJ. Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial. PLoS One. 2015 Jul 29;10(7):e0134349. doi: 10.1371/journal.pone.0134349. eCollection 2015.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LIN-MD-04
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.