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Showing 1–24 of 34 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Linaclotide Clear all
Completed Phase 3 Interventional Results available

Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

NCT04166058
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation, Functional Constipation
Interventions
Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers), Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Drug
Lead sponsor
AbbVie
Industry
Eligibility
6 Years to 18 Years
Enrollment
381 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
65
States / cities
Birmingham, Alabama • Foley, Alabama • Saraland, Alabama + 50 more
Source: ClinicalTrials.gov public record
Updated Jan 5, 2026 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional Results available

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

NCT04110145
View directory record Official record
Conditions
Functional Constipation
Interventions
Linaclotide, Placebo
Drug
Lead sponsor
Allergan
Industry
Eligibility
2 Years to 5 Years
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
18
States / cities
Birmingham, Alabama • Hot Springs, Arkansas • Little Rock, Arkansas + 15 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2022 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional Results available

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

NCT02559570
View directory record Official record
Conditions
Functional Constipation in Children Ages 6-17 Years
Interventions
Placebo, LIN Dose A, LIN Dose B, LIN Dose C, LIN 145 µg
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
6 Years to 17 Years
Enrollment
173 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
60
States / cities
Hot Springs, Arkansas • Little Rock, Arkansas • Anaheim, California + 51 more
Source: ClinicalTrials.gov public record
Updated Jun 18, 2019 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional

Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS

NCT00258193
View directory record Official record
Conditions
Irritable Bowel Syndrome
Interventions
MD-1100 Acetate
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Oct 19, 2006 · Synced Sep 4, 2026, 12:37 AM EDT
Active, not recruiting Phase 4 Interventional

Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

NCT03119584
View directory record Official record
Conditions
Chronic Constipation, Diabete Mellitus
Interventions
linaclotide or placebo
Drug
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Other
Eligibility
18 Years to 70 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2027
U.S. locations
1
States / cities
El Paso, Texas
Source: ClinicalTrials.gov public record
Updated Apr 2, 2026 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional

Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation

NCT00306748
View directory record Official record
Conditions
Constipation
Interventions
MD-1100 Acetate
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006
U.S. locations
14
States / cities
Huntsville, Alabama • North Little Rock, Arkansas • Boynton Beach, Florida + 11 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2009 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 3 Interventional Results available

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

NCT00948818
View directory record Official record
Conditions
Irritable Bowel Syndrome Characterized by Constipation
Interventions
Linaclotide 290 micrograms, Matching placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years and older
Enrollment
803 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
111
States / cities
Birmingham, Alabama • Hueytown, Alabama • Huntsville, Alabama + 94 more
Source: ClinicalTrials.gov public record
Updated Jan 29, 2013 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers

NCT01950403
View directory record Official record
Conditions
Colorectal Cancer, Healthy, no Evidence of Disease
Interventions
linaclotide acetate, placebo, pharmacological study, laboratory biomarker analysis
Drug · Other
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2018
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 8, 2024 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional Results available

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

NCT02270983
View directory record Official record
Conditions
Opioid-Induced Constipation
Interventions
Linaclotide 145 micrograms, Linaclotide 290 micrograms, Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years and older
Enrollment
254 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
77
States / cities
Anniston, Alabama • Foley, Alabama • Phoenix, Arizona + 67 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2019 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 3 Interventional Results available

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT00938717
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation
Interventions
Linaclotide or Matching Placebo
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
805 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
107
States / cities
Birmingham, Alabama • Huntsville, Alabama • Phoenix, Arizona + 97 more
Source: ClinicalTrials.gov public record
Updated Nov 4, 2013 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional Results available

Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

NCT00402337
View directory record Official record
Conditions
Chronic Constipation
Interventions
linaclotide acetate, Matching placebo
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
310 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
60
States / cities
Huntsville, Alabama • Tucson, Arizona • Sherwood, Arkansas + 55 more
Source: ClinicalTrials.gov public record
Updated Mar 4, 2013 · Synced Sep 4, 2026, 12:37 AM EDT
Terminated Phase 2 Interventional Results available

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

NCT02559817
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation
Interventions
Linaclotide Dose A, Linaclotide Dose B, Linaclotide Dose C, Linaclotide Approved Adult Dose, Matching Placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
7 Years to 17 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
46
States / cities
Hot Springs, Arkansas • Little Rock, Arkansas • Anaheim, California + 39 more
Source: ClinicalTrials.gov public record
Updated Dec 27, 2020 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 3 Interventional Results available

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

NCT02291679
View directory record Official record
Conditions
Chronic Idiopathic Constipation
Interventions
Linaclotide, Matching Placebo
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,223 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
95
States / cities
Huntsville, Alabama • Phoenix, Arizona • Tucson, Arizona + 81 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2017 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

NCT01642914
View directory record Official record
Conditions
Chronic Constipation, Constipation
Interventions
Linaclotide 290 micrograms, Linaclotide 145 micrograms, Matching placebo
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years and older
Enrollment
487 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2013
U.S. locations
146
States / cities
Chandler, Arizona • Glendale, Arizona • Goodyear, Arizona + 125 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2016 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional Results available

Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT00460811
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation
Interventions
Linaclotide Acetate, Matching placebo
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
420 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2008
U.S. locations
79
States / cities
Huntsville, Alabama • Chandler, Arizona • Tuscon, Arizona + 76 more
Source: ClinicalTrials.gov public record
Updated Feb 3, 2013 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Not applicable Interventional

Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients

NCT02078323
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
Linaclotide, Placebo
Drug
Lead sponsor
Augusta University
Other
Eligibility
18 Years to 64 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
Augusta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 22, 2018 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 1 Interventional

A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

NCT02220348
View directory record Official record
Conditions
Breast Feeding, Constipation, Irritable Bowel Syndrome
Interventions
linaclotide
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
2
States / cities
Iowa City, Iowa • Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 4, 2026, 12:37 AM EDT
Active, not recruiting Phase 2 Interventional

Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer

NCT03796884
View directory record Official record
Conditions
Colorectal Adenoma, Stage 0 Colorectal Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8
Interventions
Linaclotide, Placebo
Drug · Other
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Eligibility
18 Years to 80 Years · Female only
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
3
States / cities
Philadelphia, Pennsylvania • Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Jul 21, 2026 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 1 Interventional

GCC Agonist Signal in the Small Intestine

NCT05107219
View directory record Official record
Conditions
Barrett Esophagus, Gastroesophageal Reflux Disease, Malignant Digestive System Neoplasm
Interventions
Biopsy, Biospecimen Collection, Esophagogastroduodenoscopy, Linaclotide, Plecanatide
Procedure · Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years and older
Enrollment
43 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
4
States / cities
Scottsdale, Arizona • Philadelphia, Pennsylvania • Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 6, 2026 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 3 Interventional Results available

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT03573908
View directory record Official record
Conditions
Irritable Bowel Syndrome Characterized by Constipation
Interventions
Linaclotide, Placebo
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
614 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
79
States / cities
Huntsville, Alabama • Phoenix, Arizona • Tucson, Arizona + 67 more
Source: ClinicalTrials.gov public record
Updated Nov 30, 2020 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 4 Interventional Results available

An Open-Label, Long-term Study to Assess the Immunogenicity of LINZESS® (Linaclotide) Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation

NCT02590432
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation, Chronic Idiopathic Constipation
Interventions
Linaclotide
Drug
Lead sponsor
Forest Laboratories
Industry
Eligibility
18 Years and older
Enrollment
828 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
79
States / cities
Anniston, Alabama • Athens, Alabama • Childersburg, Alabama + 69 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2019 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 3 Interventional Results available

A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation

NCT05652205
View directory record Official record
Conditions
Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
Interventions
Placebo for Linaclotide, Linaclotide
Drug
Lead sponsor
AbbVie
Industry
Eligibility
2 Years to 5 Years
Enrollment
123 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
38
States / cities
Foley, Alabama • Phoenix, Arizona • Hot Springs, Arkansas + 33 more
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 2 Interventional Results available

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT02559206
View directory record Official record
Conditions
Irritable Bowel Syndrome With Constipation
Interventions
Linaclotide, Matching Placebo
Drug
Lead sponsor
Ironwood Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
759 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
71
States / cities
Huntsville, Alabama • Phoenix, Arizona • Tucson, Arizona + 61 more
Source: ClinicalTrials.gov public record
Updated Apr 23, 2020 · Synced Sep 4, 2026, 12:37 AM EDT
Completed Phase 4 Interventional

Single-dose Linaclotide for Capsule Endoscopy Preparation

NCT02465385
View directory record Official record
Conditions
Crohn's, Ulcerative Colitis, Gastrointestinal Bleeding
Interventions
Linaclotide
Drug
Lead sponsor
University of Virginia
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Charlottesville, Virginia
Source: ClinicalTrials.gov public record
Updated Jul 13, 2016 · Synced Sep 4, 2026, 12:37 AM EDT