Trial · NCT02729909

Lubiprostone for Chronic Idiopathic Constipation Treatment

NCT02729909, Phase 3, Completed, Takeda; results first posted 2019-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lubiprostone for Chronic Idiopathic Constipation Treatment. Trials, record NCT02729909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02729909

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Trial

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

Title: Lubiprostone for Chronic Idiopathic Constipation Treatment
NCT number: NCT02729909
Status: Completed
Phases: Phase 3
Enrollment: 211 participants, actual
Lead sponsor: Takeda
Conditions: Constipation
Interventions: Lubiprostone, Placebo
First posted: 2016-04-06
Last updated: 2019-04-01
Results first posted: 2019-04-01

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration	Week 1	A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
Secondary	SBM Frequency at Weeks 2, 3 and 4	Weeks 2, 3 and 4	A SBM is defined as any BM that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
Secondary	Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication	Up to 24 hours after the first dose of study medication	A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary.
Secondary	Mean Degree of Straining Score	Weeks 1, 2, 3 and 4	For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining was scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.
Secondary	Mean Degree of Stool Consistency	Weeks 1, 2, 3 and 4	For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).
Secondary	Weekly Abdominal Symptoms Score	Weeks 1, 2, 3 and 4	Weekly abdominal symptoms of bloating and discomfort upon waking in the morning was scored weekly on a 5-point scale where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded in the participant in the diary.

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	Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration	Week 1	Full Analysis Set (FAS) included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using last observation carried forward (LOCF).	number of SBM per week	MEAN
SECONDARY	SBM Frequency at Weeks 2, 3 and 4	Weeks 2, 3 and 4	FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.	number of SBM per week	MEAN
SECONDARY	Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication	Up to 24 hours after the first dose of study medication	FAS included all participants randomized to receive study treatment whether or not they received treatment.	percentage of participants	NUMBER
SECONDARY	Mean Degree of Straining Score	Weeks 1, 2, 3 and 4	FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.	score on a scale	MEAN
SECONDARY	Mean Degree of Stool Consistency	Weeks 1, 2, 3 and 4	FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.	score on a scale	MEAN
SECONDARY	Weekly Abdominal Symptoms Score	Weeks 1, 2, 3 and 4	FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group34

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

Outcome	Group	Category	Value	Spread	Units
Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration	Lubiprostone 24 μg		6.7	Standard Deviation 4.55	number of SBM per week
Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration	Placebo		5.2	Standard Deviation 2.82	number of SBM per week
SBM Frequency at Weeks 2, 3 and 4	Lubiprostone 24 μg	Week 2	6.9	Standard Deviation 4.40	number of SBM per week
SBM Frequency at Weeks 2, 3 and 4	Placebo	Week 2	5.5	Standard Deviation 2.75	number of SBM per week
SBM Frequency at Weeks 2, 3 and 4	Lubiprostone 24 μg	Week 3	7.6	Standard Deviation 4.50	number of SBM per week
SBM Frequency at Weeks 2, 3 and 4	Placebo	Week 3	6.0	Standard Deviation 3.74	number of SBM per week
SBM Frequency at Weeks 2, 3 and 4	Lubiprostone 24 μg	Week 4	7.2	Standard Deviation 4.21	number of SBM per week
SBM Frequency at Weeks 2, 3 and 4	Placebo	Week 4	5.8	Standard Deviation 3.39	number of SBM per week
Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication	Lubiprostone 24 μg		60.0		percentage of participants
Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication	Placebo		41.5		percentage of participants

1 to 10 of 34Source ClinicalTrials.gov

See all 34 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lubiprostone 24 μg	105
Overall Study	STARTED	Placebo	106
Overall Study	COMPLETED	Lubiprostone 24 μg	104
Overall Study	COMPLETED	Placebo	101
Overall Study	NOT COMPLETED	Lubiprostone 24 μg	1
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events54

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	Neutropenia	Blood and lymphatic system disorders	Lubiprostone 24 μg	1	105
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	106
other	Hypothyroidism	Endocrine disorders	Lubiprostone 24 μg	0	105
other	Hypothyroidism	Endocrine disorders	Placebo	1	106
other	Diarrhoea	Gastrointestinal disorders	Lubiprostone 24 μg	10	105
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	106
other	Nausea	Gastrointestinal disorders	Lubiprostone 24 μg	2	105
other	Nausea	Gastrointestinal disorders	Placebo	0	106
other	Abdominal pain	Gastrointestinal disorders	Lubiprostone 24 μg	1	105
other	Abdominal pain	Gastrointestinal disorders	Placebo	0	106

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lubiprostone 24 μg	0	105
Total, all-cause mortality	Placebo	0	106
Total, other adverse events	Lubiprostone 24 μg	23	105
Total, other adverse events	Placebo	19	106
Total, serious adverse events	Lubiprostone 24 μg	0	105
Total, serious adverse events	Placebo	0	106

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Lubiprostone 24 μg vs Placebo: deaths from any cause	Trial comparisons
Lubiprostone 24 μg vs Placebo: serious adverse events	Trial comparisons

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/NCT02729909

GET https://conductscience.org/api/trials/v1/NCT02729909/results?page=2

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