Trial · NCT00730015

Trial of Linaclotide in Patients With Chronic Constipation

NCT00730015, Phase 3, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2013-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Linaclotide in Patients With Chronic Constipation. Trials, record NCT00730015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00730015

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Linaclotide in Patients With Chronic Constipation
NCT number: NCT00730015
Status: Completed
Phases: Phase 3
Enrollment: 643 participants, actual
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Conditions: Chronic Constipation
Interventions: Matching Placebo, Linaclotide
First posted: 2008-08-08
Last updated: 2013-01-30
Results first posted: 2013-01-30

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Spontaneous Bowel Movement (CSBM) Overall Responder	Change from Baseline to Week 12	A 12-week CSBM Overall Responder was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
Secondary	12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency	Change from Baseline to Week 12	The number of CSBMs per week.
Secondary	12-Week Spontaneous Bowl Movement (SBM) Frequency	Change from Baseline to Week 12	The number of SBMs per week.
Secondary	12-week Change in Stool Consistency	Change from Baseline to Week 12	The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale: 1. = separate hard lumps like nuts \[difficult to pass\] 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges \[passed easily\] 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces \[entirely liquid\]
Secondary	12-week Change in Severity of Straining	Change from Baseline to Week 12	Severity of Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount".
Secondary	12-week Change in Abdominal Discomfort	Change from Baseline to Week 12	Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Secondary	12-week Change in Bloating	Change from Baseline to Week 12	Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Secondary	12-week Change in Constipation Severity	Change from Baseline to Week 12	Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Spontaneous Bowel Movement (CSBM) Overall Responder	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug. 642 patients were included in the Intent to Treat (ITT) Population. An observed-cases approach to missing postbaseline data was applied.	participants	NUMBER
SECONDARY	12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.	CSBMs per Week	LEAST_SQUARES_MEAN
SECONDARY	12-Week Spontaneous Bowl Movement (SBM) Frequency	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.	SBMs per Week	LEAST_SQUARES_MEAN
SECONDARY	12-week Change in Stool Consistency	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis. An observed-cases approach to missing postbaseline data was applied.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	12-week Change in Severity of Straining	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 101 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis. An observed-cases approach to missing postbaseline data was applied.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	12-week Change in Abdominal Discomfort	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	12-week Change in Bloating	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug. 642 patients were included in the ITT Population. An observed-cases approach to missing postbaseline data was applied.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	12-week Change in Constipation Severity	Change from Baseline to Week 12	643 randomized patients received at least 1 dose of study drug; 642 patients were included in the ITT Population; 10 patients who dropped out prior to finishing 1 week of the trial have missing data. An observed-cases approach to missing postbaseline data was applied.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Complete Spontaneous Bowel Movement (CSBM) Overall Responder	Linaclotide, 145μg	46		participants
Complete Spontaneous Bowel Movement (CSBM) Overall Responder	Linaclotide, 290μg	42		participants
Complete Spontaneous Bowel Movement (CSBM) Overall Responder	Placebo	7		participants
12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency	Linaclotide, 145μg	1.94	Standard Error 0.17	CSBMs per Week
12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency	Linaclotide, 290μg	2.04	Standard Error 0.17	CSBMs per Week
12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency	Placebo	0.45	Standard Error 0.17	CSBMs per Week
12-Week Spontaneous Bowl Movement (SBM) Frequency	Linaclotide, 145μg	3.03	Standard Error 0.21	SBMs per Week
12-Week Spontaneous Bowl Movement (SBM) Frequency	Linaclotide, 290μg	2.98	Standard Error 0.21	SBMs per Week
12-Week Spontaneous Bowl Movement (SBM) Frequency	Placebo	1.08	Standard Error 0.22	SBMs per Week
12-week Change in Stool Consistency	Linaclotide, 145μg	1.85	Standard Error 0.08	units on a scale

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Linaclotide, 145μg	217
Overall Study	STARTED	Linaclotide, 290μg	217
Overall Study	STARTED	Placebo	209
Overall Study	COMPLETED	Linaclotide, 145μg	186
Overall Study	COMPLETED	Linaclotide, 290μg	177
Overall Study	COMPLETED	Placebo	177
Overall Study	NOT COMPLETED	Linaclotide, 145μg	31
Overall Study	NOT COMPLETED	Linaclotide, 290μg	40
Overall Study	NOT COMPLETED	Placebo	32

Source ClinicalTrials.gov

Adverse events96

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Linaclotide 145μg	27	217
other	Diarrhea	Gastrointestinal disorders	Linaclotide 290μg	30	217
other	Diarrhea	Gastrointestinal disorders	Placebo	14	209
other	Diarrhea	Gastrointestinal disorders	Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period	20	177
other	Diarrhea	Gastrointestinal disorders	Linaclotide 145μg to Placebo RW Period	1	95
other	Diarrhea	Gastrointestinal disorders	Linaclotide 145μg to Linaclotide 145μg RW Period	2	90
other	Diarrhea	Gastrointestinal disorders	Linaclotide 290μg to Placebo RW Period	0	86
other	Diarrhea	Gastrointestinal disorders	Linaclotide 290μg to Linaclotide 290μg RW Period	1	90
serious	Gastroenteritis viral	Infections and infestations	Linaclotide 145μg	0	217	0
serious	Gastroenteritis viral	Infections and infestations	Linaclotide 290μg	0	217	0

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Linaclotide 145μg
Total, all-cause mortality	Linaclotide 290μg
Total, all-cause mortality	Placebo
Total, all-cause mortality	Placebo to Linaclotide 290μg Randomized Withdrawal (RW) Period
Total, all-cause mortality	Linaclotide 145μg to Placebo RW Period
Total, all-cause mortality	Linaclotide 145μg to Linaclotide 145μg RW Period
Total, all-cause mortality	Linaclotide 290μg to Placebo RW Period
Total, all-cause mortality	Linaclotide 290μg to Linaclotide 290μg RW Period
Total, other adverse events	Linaclotide 145μg	27	217
Total, other adverse events	Linaclotide 290μg	30	217

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21830967	DERIVED	PubMed
25312449	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00730015

GET https://conductscience.org/api/trials/v1/NCT00730015/results?page=2

API reference For AI assistants