Trial · NCT03097861

Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

NCT03097861, Phase 3, Completed, Sucampo Pharma Americas, LLC; results first posted 2020-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo. Trials, record NCT03097861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03097861

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Trial

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

Title: Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
NCT number: NCT03097861
Status: Completed
Phases: Phase 3
Enrollment: 552 participants, actual
Lead sponsor: Sucampo Pharma Americas, LLC
Conditions: Chronic Idiopathic Constipation
Interventions: Lubiprostone, Placebo
First posted: 2017-03-31
Last updated: 2020-01-14
Results first posted: 2020-01-14
Limitations and caveats: Actual randomization ratio (2:1:1) was different than the planned ratio (1:1:1).

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	during the 1-week treatment period	Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.
Secondary	Mean SBM Consistency Score Within 1 Week	during the 1-week treatment period	Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the 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. Scores in the mid-range of this scale indicate better stool consistency.
Secondary	Mean SBM Straining Score Within 1 Week	during the 1-week treatment period	Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study medication to follow-up (up to 15 days)	An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	during the 1-week treatment period	Per protocol population	SBMs/week	MEAN
SECONDARY	Mean SBM Consistency Score Within 1 Week	during the 1-week treatment period	PP population. Number of participants analysed indicates participants who were evaluated for this outcome measure at each categorical time point.	score on a scale	MEAN
SECONDARY	Mean SBM Straining Score Within 1 Week	during the 1-week treatment period	PP population. Number of participants analysed indicates participants who were evaluated for this outcome measure at each time point.	score on a scale	MEAN
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of study medication to follow-up (up to 15 days)	Safety population, defined as all randomized participants who took at least one dose of double-blinded study medication.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	Placebo	Baseline	1.38	Standard Deviation 0.692	SBMs/week
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	Lubiprostone Sprinkle	Baseline	1.37	Standard Deviation 0.693	SBMs/week
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	Lubiprostone Capsule	Baseline	1.35	Standard Deviation 0.720	SBMs/week
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	Placebo	Week 1	3.68	Standard Deviation 2.164	SBMs/week
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	Lubiprostone Sprinkle	Week 1	4.82	Standard Deviation 3.658	SBMs/week
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week	Lubiprostone Capsule	Week 1	5.74	Standard Deviation 3.786	SBMs/week
Mean SBM Consistency Score Within 1 Week	Placebo	Baseline	2.47	Standard Deviation 1.122	score on a scale
Mean SBM Consistency Score Within 1 Week	Lubiprostone Sprinkle	Baseline	2.39	Standard Deviation 1.211	score on a scale
Mean SBM Consistency Score Within 1 Week	Lubiprostone Capsule	Baseline	2.28	Standard Deviation 1.045	score on a scale
Mean SBM Consistency Score Within 1 Week	Placebo	Week 1	3.43	Standard Deviation 1.270	score on a scale

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow21

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	145
Overall Study	STARTED	Lubiprostone Sprinkle	276
Overall Study	STARTED	Lubiprostone Capsule	131
Overall Study	Safety Population	Placebo	143
Overall Study	Safety Population	Lubiprostone Sprinkle	275
Overall Study	Safety Population	Lubiprostone Capsule	130
Overall Study	Modified Intent to Treat	Placebo	143
Overall Study	Modified Intent to Treat	Lubiprostone Sprinkle	275
Overall Study	Modified Intent to Treat	Lubiprostone Capsule	130
Overall Study	Completers	Placebo	129

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events15

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	Diarrhea	Gastrointestinal disorders	Placebo	4	143
other	Diarrhea	Gastrointestinal disorders	Lubiprostone Sprinkle	22	275
other	Diarrhea	Gastrointestinal disorders	Lubiprostone Capsule	13	130
other	Nausea	Gastrointestinal disorders	Placebo	3	143
other	Nausea	Gastrointestinal disorders	Lubiprostone Sprinkle	10	275
other	Nausea	Gastrointestinal disorders	Lubiprostone Capsule	11	130
other	Abdominal pain	Gastrointestinal disorders	Placebo	3	143
other	Abdominal pain	Gastrointestinal disorders	Lubiprostone Sprinkle	4	275
other	Abdominal pain	Gastrointestinal disorders	Lubiprostone Capsule	4	130
other	Vomiting	Gastrointestinal disorders	Placebo	0	143

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	143
Total, all-cause mortality	Lubiprostone Sprinkle	0	275
Total, all-cause mortality	Lubiprostone Capsule	0	130
Total, other adverse events	Placebo	15	143
Total, other adverse events	Lubiprostone Sprinkle	50	275
Total, other adverse events	Lubiprostone Capsule	29	130
Total, serious adverse events	Placebo	0	143
Total, serious adverse events	Lubiprostone Sprinkle	0	275
Total, serious adverse events	Lubiprostone Capsule	0	130

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33834354	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.

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Read this trial from software.

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