Trial · NCT01642914

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

NCT01642914, Phase 3, Completed, Forest Laboratories; results first posted 2016-04-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating. Trials, record NCT01642914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01642914

On this page

Trial

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

Title: Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating
NCT number: NCT01642914
Status: Completed
Phases: Phase 3
Enrollment: 487 participants, actual
Lead sponsor: Forest Laboratories
Conditions: Chronic Constipation, Constipation
Interventions: Linaclotide 290 micrograms, Linaclotide 145 micrograms, Matching placebo
First posted: 2012-07-17
Last updated: 2016-04-26
Results first posted: 2016-04-26

Source ClinicalTrials.gov

Registered outcomes24

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

List	Outcome	Time frame	Description
Primary	9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	12-week treatment period	A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.
Secondary	9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	12-week treatment period	A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.
Secondary	Change From Baseline in 12-Week Abdominal Bloating	Baseline and 12-week treatment period	Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.
Secondary	Percent Change From Baseline in 12-week Abdominal Bloating	Baseline and 12-week treatment period	Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.
Secondary	Percent Change From Baseline in Abdominal Bloating at Week 12	Baseline and Week 12	Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.
Secondary	6/12 Week Abdominal Bloating 30% Responder	12-week treatment period	A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient's improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.
Secondary	Change From Baseline in 12-week CSBM Frequency Rate	Baseline and 12-week treatment period	A patient's 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.
Secondary	Change From Baseline in CSBM Frequency Rate at Week 1.	Baseline and Week 1	A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.
Secondary	Change From Baseline in CSBM Frequency Rate at Week 4.	Baseline and Week 4	A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.
Secondary	Change From Baseline in CSBM Frequency Rate at Week 8	Baseline and Week 8	A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week. Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	12-week treatment period	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	participants	NUMBER
SECONDARY	Change From Baseline in 12-Week Abdominal Bloating	Baseline and 12-week treatment period	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	units on a scale	MEAN
SECONDARY	Percent Change From Baseline in 12-week Abdominal Bloating	Baseline and 12-week treatment period	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	percentage change of NRS score	MEAN
SECONDARY	Percent Change From Baseline in Abdominal Bloating at Week 12	Baseline and Week 12	Reported outcome data is based on the 483 patient Intent-to-Treat Population. The distribution of each of the linaclotide groups was compared, in a pair-wise manner, to the placebo group using the two-sample Kolmogorov-Smirnov test.	percentage change in abdominal bloating	MEAN
SECONDARY	6/12 Week Abdominal Bloating 30% Responder	12-week treatment period	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	participants	NUMBER
SECONDARY	Change From Baseline in 12-week CSBM Frequency Rate	Baseline and 12-week treatment period	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	CSBMs per week	MEAN
SECONDARY	Change From Baseline in CSBM Frequency Rate at Week 1.	Baseline and Week 1	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	CSBMs per week	MEAN
SECONDARY	Change From Baseline in CSBM Frequency Rate at Week 4.	Baseline and Week 4	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	CSBMs per week	MEAN
SECONDARY	Change From Baseline in CSBM Frequency Rate at Week 8	Baseline and Week 8	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	CSBMs per week	MEAN
SECONDARY	Change From Baseline in CSBM Frequency Rate at Week 12	Baseline and Week 12	487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population	CSBMs per week	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group83

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

Outcome	Group	Category	Value	Spread	Units
9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	Placebo	Responder	13		participants
9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	Linaclotide 290 Micrograms	Responder	26		participants
9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	Placebo	Nonresponder	158		participants
9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder	Linaclotide 290 Micrograms	Nonresponder	133		participants
Change From Baseline in 12-Week Abdominal Bloating	Placebo		-1.583	Standard Deviation 1.988	units on a scale
Change From Baseline in 12-Week Abdominal Bloating	Linaclotide 145 Micrograms		-2.476	Standard Deviation 2.315	units on a scale
Change From Baseline in 12-Week Abdominal Bloating	Linaclotide 290 Micrograms		-2.456	Standard Deviation 2.240	units on a scale
Percent Change From Baseline in 12-week Abdominal Bloating	Placebo		-22.65	Standard Deviation 29.19	percentage change of NRS score
Percent Change From Baseline in 12-week Abdominal Bloating	Linaclotide 145 Micrograms		-34.52	Standard Deviation 31.79	percentage change of NRS score
Percent Change From Baseline in 12-week Abdominal Bloating	Linaclotide 290 Micrograms		-34.22	Standard Deviation 30.65	percentage change of NRS score

1 to 10 of 83Source ClinicalTrials.gov

See all 83 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	173
Overall Study	STARTED	Linaclotide 145 Micrograms	154
Overall Study	STARTED	Linaclotide 290 Micrograms	160
Overall Study	COMPLETED	Placebo	127
Overall Study	COMPLETED	Linaclotide 145 Micrograms	122
Overall Study	COMPLETED	Linaclotide 290 Micrograms	120
Overall Study	NOT COMPLETED	Placebo	46
Overall Study	NOT COMPLETED	Linaclotide 145 Micrograms	32
Overall Study	NOT COMPLETED	Linaclotide 290 Micrograms	40

Source ClinicalTrials.gov

Adverse events36

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	Diarrhoea	Gastrointestinal disorders	Placebo	4	173
other	Diarrhoea	Gastrointestinal disorders	Linaclotide 145 Micrograms	9	153
other	Diarrhoea	Gastrointestinal disorders	Linaclotide 290 Micrograms	27	160
other	Upper respiratory tract infection	Infections and infestations	Placebo	5	173
other	Upper respiratory tract infection	Infections and infestations	Linaclotide 145 Micrograms	9	153
other	Upper respiratory tract infection	Infections and infestations	Linaclotide 290 Micrograms	5	160
other	Sinusitis	Infections and infestations	Placebo	3	173
other	Sinusitis	Infections and infestations	Linaclotide 145 Micrograms	9	153
other	Sinusitis	Infections and infestations	Linaclotide 290 Micrograms	2	160
serious	brain stem infarction	Nervous system disorders	Placebo	1	173

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Linaclotide 145 Micrograms
Total, all-cause mortality	Linaclotide 290 Micrograms
Total, other adverse events	Placebo	12	173
Total, other adverse events	Linaclotide 145 Micrograms	25	153
Total, other adverse events	Linaclotide 290 Micrograms	33	160
Total, serious adverse events	Placebo	2	173
Total, serious adverse events	Linaclotide 145 Micrograms	4	153
Total, serious adverse events	Linaclotide 290 Micrograms	2	160

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26222318	DERIVED	PubMed
33428631	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/NCT01642914

GET https://conductscience.org/api/trials/v1/NCT01642914/registered?page=2

API reference For AI assistants