Trial · NCT00402337

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

NCT00402337, Phase 2, Completed, Ironwood Pharmaceuticals, Inc.; results first posted 2013-03-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation. Trials, record NCT00402337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00402337

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Trial

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

Title: Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
NCT number: NCT00402337
Status: Completed
Phases: Phase 2
Enrollment: 310 participants, actual
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Conditions: Chronic Constipation
Interventions: linaclotide acetate, Matching placebo
First posted: 2006-11-22
Last updated: 2013-03-05
Results first posted: 2013-03-05

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Change from Baseline to Week 4	Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.
Secondary	SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Change from Baseline to Week 4	A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate.
Secondary	CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Change from Baseline to Week 4	A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from their baseline weekly CSBM rate.
Secondary	Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period	Change from Baseline to Week 4	CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?
Secondary	Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period	Change from Baseline to Week 4	Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = 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; and 7 = entirely liquid.
Secondary	Change From Baseline in Straining Score for the Treatment Period	Change from Baseline to Week 4	Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Change from Baseline to Week 4	307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the intent-to-treat (ITT) Population.	SBMs per week	LEAST_SQUARES_MEAN
SECONDARY	SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Change from Baseline to Week 4	307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population.	participants	NUMBER
SECONDARY	CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Change from Baseline to Week 4	307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population.	participants	NUMBER
SECONDARY	Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period	Change from Baseline to Week 4	307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population.	CSBMs per week	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period	Change from Baseline to Week 4	307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Stool Consistency analysis.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Straining Score for the Treatment Period	Change from Baseline to Week 4	307 patients who received ≥ 1 capsule of study drug and had ≥ 1 post-baseline response to the IVRS Treatment Period Question #12 How many bowel movements did you have today or yesterday since your last call? were included in the ITT Population. 29 patients with no pretreatment spontaneous bowel movements were excluded from the Straining analysis.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Value	Spread	Units
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Linaclotide, 72μg	2.59	Standard Error 0.407	SBMs per week
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Linaclotide, 145μg	3.25	Standard Error 0.412	SBMs per week
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Linaclotide, 290μg	3.57	Standard Error 0.391	SBMs per week
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Linaclotide, 579μg	4.29	Standard Error 0.394	SBMs per week
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Placebo	1.45	Standard Error 0.383	SBMs per week
SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Linaclotide, 72μg	35		participants
SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Linaclotide, 145μg	31		participants
SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Linaclotide, 290μg	38		participants
SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Linaclotide, 579μg	42		participants
SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	Placebo	22		participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Linaclotide, 72μg	59
Overall Study	STARTED	Linaclotide, 145μg	57
Overall Study	STARTED	Linaclotide, 290μg	62
Overall Study	STARTED	Linaclotide, 579μg	63
Overall Study	STARTED	Placebo	69
Overall Study	COMPLETED	Linaclotide, 72μg	54
Overall Study	COMPLETED	Linaclotide, 145μg	51
Overall Study	COMPLETED	Linaclotide, 290μg	58
Overall Study	COMPLETED	Linaclotide, 579μg	51
Overall Study	COMPLETED	Placebo	61

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events30

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
other	Abdominal pain	Gastrointestinal disorders	Linaclotide, 72μg	2	59
other	Abdominal pain	Gastrointestinal disorders	Linaclotide, 145μg	5	56
other	Abdominal pain	Gastrointestinal disorders	Linaclotide, 290μg	2	62
other	Abdominal pain	Gastrointestinal disorders	Linaclotide, 579μg	2	63
other	Abdominal pain	Gastrointestinal disorders	Placebo	3	69
other	Diarrhea	Gastrointestinal disorders	Linaclotide, 72μg	3	59
other	Diarrhea	Gastrointestinal disorders	Linaclotide, 145μg	5	56
other	Diarrhea	Gastrointestinal disorders	Linaclotide, 290μg	3	62
other	Diarrhea	Gastrointestinal disorders	Linaclotide, 579μg	9	63
other	Diarrhea	Gastrointestinal disorders	Placebo	2	69

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Linaclotide, 72μg
Total, all-cause mortality	Linaclotide, 145μg
Total, all-cause mortality	Linaclotide, 290μg
Total, all-cause mortality	Linaclotide, 579μg
Total, all-cause mortality	Placebo
Total, other adverse events	Linaclotide, 72μg	7	59
Total, other adverse events	Linaclotide, 145μg	11	56
Total, other adverse events	Linaclotide, 290μg	5	62
Total, other adverse events	Linaclotide, 579μg	11	63
Total, other adverse events	Placebo	7	69

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20045700	DERIVED

Source 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/NCT00402337

GET https://conductscience.org/api/trials/v1/NCT00402337/results?page=2

API reference For AI assistants