Irritable Bowel Syndrome With ConstipationPhase 2NCT02559206

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

A Phase 2 study testing Linaclotide in people with Irritable Bowel Syndrome With Constipation, run by Ironwood Pharmaceuticals, Inc. at 71 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Irritable Bowel Syndrome With Constipation
What is being tested?: Linaclotide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 759 participants
Where: 71 sitesUnited States
Study dates: 22 Oct 2015to 30 Sep 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for diagnosis of IBS-C
Patient demonstrates continued IBS-C through Pretreatment Period
Patient maintains a minimum level of compliance with daily diary

Who cannot join

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
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 could confound the study assessments

Trial locations and contacts

71 sites in 1 country.

City, postcode or hospital

71 sites in 1 country

United States71 sites

Ironwood Investigational Site
Anaheim, California, 92801
Ironwood Investigational Site
Arlington, Texas, 76012
Ironwood Investigational Site
Atlanta, Georgia, 30328
Ironwood Investigational Site
Baltimore, Maryland, 21215
Ironwood Investigational Site
Bastrop, Louisiana, 71220
Ironwood Investigational Site
Beaumont, Texas, 77001
Ironwood Investigational Site
Boston, Massachusetts, 02131
Ironwood Investigational Site
Bozeman, Montana, 59718
Ironwood Investigational Site
Bristol, Connecticut, 06010
Ironwood Investigational Site
Bristol, Tennessee, 37620
Ironwood Investigational Site
Brooklyn, New York, 11206
Ironwood Investigational Site
Charlotte, North Carolina, 28210
Ironwood Investigational Site
Chattanooga, Tennessee, 37421
Ironwood Investigational Site
Chesterfield, Michigan, 48047
Ironwood Investigational Site
Chevy Chase, Maryland, 20815
Ironwood Investigational Site
Christiansburg, Virginia, 24073
Ironwood Investigational Site
Chula Vista, California, 91910
Ironwood Investigational Site
Cincinnati, Ohio, 45219
Ironwood Investigational Site
Cincinnati, Ohio, 45224
Ironwood Investigational Site
Colorado Springs, Colorado, 80904
Ironwood Investigational Site
Concord, North Carolina, 28025
Ironwood Investigational Site
Dakota Dunes, South Dakota, 57049
Ironwood Investigational Site
Davidson, North Carolina, 28036
Ironwood Investigational Site
El Paso, Texas, 79905
Ironwood Investigational Site
Evansville, Indiana, 47714
Ironwood Investigational Site
Fayetteville, North Carolina, 28304
Ironwood Investigational Site
Garden Grove, California, 92843
Ironwood Investigational Site
Hialeah, Florida, 33016
Ironwood Investigational Site
Houston, Texas, 77074
Ironwood Investigational Site
Huntsville, Alabama, 35801
Ironwood Investigational Site
Jackson, Mississippi, 39202
Ironwood Investigational Site
Kissimmee, Florida, 34744
Ironwood Investigational Site
Knoxville, Tennessee, 37909
Ironwood Investigational Site
La Crosse, Wisconsin, 54601
Ironwood Investigational Site
La Mesa, California, 91942
Ironwood Investigational Site
Las Vegas, Nevada, 89119
Ironwood Investigational Site
Las Vegas, Nevada, 89121
Ironwood Investigational Site
Lynchburg, Virginia, 24502
Ironwood Investigational Site
Mentor, Ohio, 44060
Ironwood Investigational Site
Metairie, Louisiana, 70006
Ironwood Investigational Site
Miami, Florida, 33015
Ironwood Investigational Site
Miami, Florida, 33135
Ironwood Investigational Site
Miami, Florida, 33165
Ironwood Investigational Site
Miami, Florida, 33175
Ironwood Investigational Site
Newport Beach, California, 92660
Ironwood Investigational Site
North Little Rock, Arkansas, 72117
Ironwood Investigational Site
Oakwood, Georgia, 30566
Ironwood Investigational Site
Ogden, Utah, 84405
Ironwood Investigational Site
Orange, California, 92868
Ironwood Investigational Site
Orlando, Florida, 32806
Ironwood Investigational Site
Phoenix, Arizona, 85018
Ironwood Investigational Site
Pittsburgh, Pennsylvania, 15206
Ironwood Investigational Site
San Antonio, Texas, 78209
Ironwood Investigational Site
San Antonio, Texas, 78229
Ironwood Investigational Site
San Antonio, Texas, 78258
Ironwood Investigational Site
San Diego, California, 92108
Ironwood Investigational Site
Sandy City, Utah, 84094
Ironwood Investigational Site
Sandy Springs, Georgia, 30328
Ironwood Investigational Site
Shreveport, Louisiana, 71105
Ironwood Investigational Site
South Miami, Florida, 33143
Ironwood Investigational Site
St Louis, Missouri, 63128-2197
Ironwood Investigational Site
Tampa, Florida, 33634
Ironwood Investigational Site
Thousand Oaks, California, 91360
Ironwood Investigational Site
Tucson, Arizona, 85712
Ironwood Investigational Site
Waterbury, Connecticut, 06708
Ironwood Investigational Site
Watertown, Massachusetts, 02472
Ironwood Investigational Site
West Palm Beach, Florida, 33409
Ironwood Investigational Site
Wilmington, North Carolina, 28401
Ironwood Investigational Site
Winston-Salem, North Carolina, 27103
Ironwood Investigational Site
Wyoming, Michigan, 49519
Ironwood Investigational Site
Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).

Conditions: Irritable Bowel Syndrome With Constipation
Being tested: Linaclotide, Matching Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LinaclotideDrug
Oral, once daily
Matching PlaceboDrug
Oral, once daily

Study groups in NCT02559206
Study group	Role	What they receive
30 μg linaclotide DR1 and placebo	Experimental	Not described Receives: Drug: Linaclotide
100 μg linaclotide DR1 and placebo	Experimental	Not described Receives: Drug: Linaclotide
300 μg linaclotide DR1 and placebo	Experimental	Not described Receives: Drug: Linaclotide
30 μg linaclotide DR2 and placebo	Experimental	Not described Receives: Drug: Linaclotide
100 μg linaclotide DR2 and placebo	Experimental	Not described Receives: Drug: Linaclotide
300 μg linaclotide DR2 and placebo	Experimental	Not described Receives: Drug: Linaclotide
290 μg linaclotide IR and placebo	Experimental	Not described Receives: Drug: Linaclotide
Placebo	Placebo comparator	Not described Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Measured: Baseline, up to Week 12
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Measured: Baseline, up to Week 12
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Measured: Baseline, up to Week 12
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Measured: Baseline, up to Week 12
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.
- Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.
- Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.
- Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.
A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.
Measured: up to Week 12
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.
- Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.
- Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.
- Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.
A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.
Measured: up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 201530 Sep 2016

First posted24 Sep 2015 (estimated)
Study start22 Oct 2015
Primary completion30 Sep 2016
Study completion30 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 759 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02559206
Sponsor's protocol ID: MCP-103-204
Status last verified: Apr 2020
First submitted: 22 Sep 2015
Last updated: 24 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chey WD, Sayuk GS, Bartolini W, Reasner DS, Fox SM, Bochenek W, Boinpally R, Shea E, Tripp K, Borgstein N. Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. Am J Gastroenterol. 2021 Feb 1;116(2):354-361. doi: 10.14309/ajg.0000000000000967.
PubMed 33065589

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2/3
Home Transcutaneous Electrical Acustimulation (TEA)
Irritable Bowel Syndrome With Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation

All Irritable Bowel Syndrome With Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation
ClinicalTrials.gov ID: NCT02559206
Acronym / sponsor ID: MCP-103-204
Conditions: Irritable Bowel Syndrome With Constipation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 759 participants (actual)
Lead sponsor: Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Forest Laboratories
Study start: 22 Oct 2015 (actual)
Primary completion: 30 Sep 2016 (actual)
Study completion: 30 Sep 2016 (actual)
First posted: 24 Sep 2015 (estimated)
Results: Posted 24 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
30 μg linaclotide DR1 and placebo	Experimental	Drug: Linaclotide
100 μg linaclotide DR1 and placebo	Experimental	Drug: Linaclotide
300 μg linaclotide DR1 and placebo	Experimental	Drug: Linaclotide
30 μg linaclotide DR2 and placebo	Experimental	Drug: Linaclotide
100 μg linaclotide DR2 and placebo	Experimental	Drug: Linaclotide
300 μg linaclotide DR2 and placebo	Experimental	Drug: Linaclotide
290 μg linaclotide IR and placebo	Experimental	Drug: Linaclotide
Placebo	Placebo comparator	Drug: Matching Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
Patient has no clinically significant findings on a physical examination and clinical laboratory tests
Patient meets protocol criteria for diagnosis of IBS-C
Patient demonstrates continued IBS-C through Pretreatment Period
Patient maintains a minimum level of compliance with daily diary

Key exclusion criteria (4 listed)

Patient has history of loose or watery stools
Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
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 could confound the study assessments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LinaclotideOral, once daily	Drug	100 μg linaclotide DR1 and placebo, 100 μg linaclotide DR2 and placebo, 290 μg linaclotide IR and placebo, 30 μg linaclotide DR1 and placebo, 30 μg linaclotide DR2 and placebo, 300 μg linaclotide DR1 and placebo, 300 μg linaclotide DR2 and placebo
Matching PlaceboOral, once daily	Drug	Placebo

Primary outcome

Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Time frame: Baseline, up to Week 12
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Time frame: Baseline, up to Week 12
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Time frame: Baseline, up to Week 12
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Time frame: Baseline, up to Week 12
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Time frame: up to Week 12
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Time frame: up to Week 12
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.

Results and safety

Results posted to the registry on 24 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	66	58
Linaclotide IR 290 μg	66	54
Linaclotide DR1 30 μg	67	58
Linaclotide DR1 100 μg	67	53
Linaclotide DR1 300 μg	67	55
Linaclotide DR2 30 μg	67	53
Linaclotide DR2 100 μg	66	60
Linaclotide DR2 300 μg	66	57

Primary outcome: Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

Time frame: Baseline, up to Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 66	Linaclotide IR 290 μg n = 66	Linaclotide DR1 30 μg n = 67	Linaclotide DR1 100 μg n = 67	Linaclotide DR1 300 μg n = 67
Value	-1.370 (0.241)	-1.938 (0.241)	-1.667 (0.234)	-1.656 (0.240)	-2.140 (0.236)

Placebo vs Linaclotide IR 290 μg: LS Mean Difference (Lin-Placebo): -0.569 (95% CI -1.214 to 0.076), p = 0.0839, mixed model repeated measures (MMRM)
Placebo vs Linaclotide DR1 30 μg: LS Mean Difference (Lin-Placebo): -0.297 (95% CI -0.942 to 0.348), p = 0.3661, MMRM
Placebo vs Linaclotide DR1 100 μg: LS Mean Difference (Lin-Placebo): -0.286 (95% CI -0.936 to 0.363), p = 0.3869, MMRM

Population analysed: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).

Primary outcome: Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

Time frame: Baseline, up to Week 12. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 66	Linaclotide IR 290 μg n = 66	Linaclotide DR2 30 μg n = 67	Linaclotide DR2 100 μg n = 66	Linaclotide DR2 300 μg n = 66
Value	-1.370 (0.241)	-1.938 (0.241)	-1.825 (0.238)	-1.669 (0.235)	-1.628 (0.239)

Placebo vs Linaclotide IR 290 μg: LS Mean Difference (Lin-Placebo): -0.569 (95% CI -1.214 to 0.076), p = 0.0839, MMRM
Placebo vs Linaclotide DR2 30 μg: LS Mean Difference (Lin-Placebo): -0.455 (95% CI -1.102 to 0.191), p = 0.1669, MMRM
Placebo vs Linaclotide DR2 100 μg: LS Mean Difference (Lin-Placebo): -0.299 (95% CI -0.947 to 0.348), p = 0.3637, MMRM

Population analysed: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).

Primary outcome: Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

Time frame: Baseline, up to Week 12. Least squares mean (Standard Error). Unit: CSBMs/week

Measure	Placebo n = 66	Linaclotide IR 290 μg n = 66	Linaclotide DR1 30 μg n = 67	Linaclotide DR1 100 μg n = 67	Linaclotide DR1 300 μg n = 67
Value	1.115 (0.285)	2.107 (0.286)	1.163 (0.278)	1.414 (0.283)	1.776 (0.279)

Placebo vs Linaclotide IR 290 μg: LS Mean Difference (Lin-Placebo): 0.992 (95% CI 0.228 to 1.756), p = 0.0110, MMRM
Placebo vs Linaclotide DR1 30 μg: LS Mean Difference (Lin-Placebo): 0.048 (95% CI -0.716 to 0.812), p = 0.9013, MMRM
Linaclotide DR1 100 μg: LS Mean Difference (Lin-Placebo): 0.299 (95% CI -0.469 to 1.067), p = 0.4447, MMRM

Population analysed: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).

Primary outcome: Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

Time frame: Baseline, up to Week 12. Least squares mean (Standard Error). Unit: CSBMs/week

Measure	Placebo n = 66	Linaclotide IR 290 μg n = 66	Linaclotide DR2 30 μg n = 67	Linaclotide DR2 100 μg n = 66	Linaclotide DR2 300 μg n = 66
Value	1.115 (0.285)	2.107 (0.286)	1.275 (0.282)	1.019 (0.278)	0.869 (0.282)

Placebo vs Linaclotide IR 290 μg: LS Mean Difference (Lin-Placebo): 0.992 (95% CI 0.228 to 1.756), p = 0.0110, MMRM
Placebo vs Linaclotide DR2 30 μg: LS Mean Difference (Lin-Placebo): 0.161 (95% CI -0.604 to 0.925), p = 0.6801, MMRM
Placebo vs Linaclotide DR2 100 μg: LS Mean Difference (Lin-Placebo): -0.095 (95% CI -0.861 to 0.670), p = 0.8069, MMRM

Population analysed: Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).

Adverse events

Time frame: From the first dose of study drug through Week 12/End-of-Treatment Period Visit (Day 85+3). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 66 (1.5%)	1 of 66 (1.5%)	0 of 66
Linaclotide IR 290 μg	1 of 66 (1.5%)	10 of 66 (15.2%)	0 of 66
Linaclotide DR1 30 μg	0 of 67 (0%)	4 of 67 (6%)	0 of 67
Linaclotide DR1 100 μg	0 of 67 (0%)	9 of 67 (13.4%)	0 of 67
Linaclotide DR1 300 μg	0 of 67 (0%)	8 of 67 (11.9%)	0 of 67
Linaclotide DR2 30 μg	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Linaclotide DR2 100 μg	0 of 66 (0%)	1 of 66 (1.5%)	0 of 66
Linaclotide DR2 300 μg	0 of 66 (0%)	2 of 66 (3%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33065589Chey WD, Sayuk GS, Bartolini W, Reasner DS, Fox SM, Bochenek W, Boinpally R, Shea E, Tripp K, Borgstein N. Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. Am J Gastroenterol. 2021 Feb 1;116(2):354-361. doi: 10.14309/ajg.0000000000000967.

Related trials for Irritable Bowel Syndrome With Constipation

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Chamberlin, MD study chair

Ironwood Pharmaceuticals, Inc.

71 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Linaclotide in people with Irritable Bowel Syndrome With Constipation, run by Ironwood Pharmaceuticals, Inc. at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo (time frame: Baseline, up to Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02559206, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.