Trial · NCT00597428

Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

NCT00597428, Phase 3, Completed, Sucampo Pharma Americas, LLC; results first posted 2015-12-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone. Trials, record NCT00597428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597428

On this page

Trial

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

Title: Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
NCT number: NCT00597428
Status: Completed
Phases: Phase 3
Enrollment: 437 participants, actual
Lead sponsor: Sucampo Pharma Americas, LLC
Conditions: Opioid-Induced Bowel Dysfunction
Interventions: Lubiprostone, Placebo
First posted: 2008-01-18
Last updated: 2019-12-10
Results first posted: 2015-12-07
Limitations and caveats: Post-study, it was determined that lubiprostone efficacy was dose-dependently decreased with concomitant methadone use (30% higher morphine equivalent daily dose (MEDD) than parallel pivotal study NCT00595946).

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 Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8	Baseline and Week 8
Secondary	Change From Baseline in Mean Weekly SBM Frequency	Baseline, Week 12, and Weeks 1-12	For overall assessment of change, average weekly rating was calculated from data collected from Week 1 through Week 12.
Secondary	First Post-dose SBM	24 and 48 hours post-dose	The number of participants that experienced first post-dose SBM 24 and 48 hour of dose initiation.
Secondary	Responder Rate	Up to 12 weeks	Number of participants, who remained on treatment for at least 8 weeks, and reported response (\>=3 SBMs) for at least 50% of weeks on study.
Secondary	Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity	Weeks 1-12	Ratings over 12-week treatment period were averaged and difference from baseline score calculated Straining scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Stool consistency scale: 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) Constipation severity scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal bloating scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Abdominal discomfort scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe Bowel habit regularity scale: 7-point scale, where 1 = very regular and 7 = very irregular
Secondary	Treatment Effectiveness	Weeks 1-12	Treatment effectiveness scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective

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 Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8	Baseline and Week 8		Spontaneous Bowel Movements/Week	MEAN
SECONDARY	Change From Baseline in Mean Weekly SBM Frequency	Baseline, Week 12, and Weeks 1-12		Spontaneous Bowel Movements/Week	MEAN
SECONDARY	First Post-dose SBM	24 and 48 hours post-dose		participants	NUMBER
SECONDARY	Responder Rate	Up to 12 weeks		participants	NUMBER
SECONDARY	Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity	Weeks 1-12		units on a scale	MEAN
SECONDARY	Treatment Effectiveness	Weeks 1-12	Treatment effectiveness scores were collected at the end of each treatment week during the study; the number of participants analyzed reflects those subjects who provided at least one end-of-week assessment of treatment effectiveness. For the analysis, treatment effectiveness scores were averaged across the treatment period (Weeks 1-12).	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group26

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8	Placebo		2.4	Standard Deviation 3.20	Spontaneous Bowel Movements/Week
Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8	Lubiprostone		2.6	Standard Deviation 3.26	Spontaneous Bowel Movements/Week
Change From Baseline in Mean Weekly SBM Frequency	Placebo	Week 12	2.6	Standard Deviation 3.57	Spontaneous Bowel Movements/Week
Change From Baseline in Mean Weekly SBM Frequency	Lubiprostone	Week 12	2.5	Standard Deviation 3.64	Spontaneous Bowel Movements/Week
Change From Baseline in Mean Weekly SBM Frequency	Placebo	Overall	2.3	Standard Deviation 2.57	Spontaneous Bowel Movements/Week
Change From Baseline in Mean Weekly SBM Frequency	Lubiprostone	Overall	2.6	Standard Deviation 2.73	Spontaneous Bowel Movements/Week
First Post-dose SBM	Placebo	24 hours	64		participants
First Post-dose SBM	Lubiprostone	24 hours	74		participants
First Post-dose SBM	Placebo	48 hours	118		participants
First Post-dose SBM	Lubiprostone	48 hours	136		participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	214
Overall Study	STARTED	Lubiprostone	223
Overall Study	COMPLETED	Placebo	153
Overall Study	COMPLETED	Lubiprostone	152
Overall Study	NOT COMPLETED	Placebo	61
Overall Study	NOT COMPLETED	Lubiprostone	71

Source ClinicalTrials.gov

Adverse events42

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	Nausea	Gastrointestinal disorders	Placebo	19	214
other	Nausea	Gastrointestinal disorders	Lubiprostone	33	223
other	Diarrhoea	Gastrointestinal disorders	Placebo	9	214
other	Diarrhoea	Gastrointestinal disorders	Lubiprostone	18	223
other	Flatulence	Gastrointestinal disorders	Placebo	9	214
other	Flatulence	Gastrointestinal disorders	Lubiprostone	13	223
other	Vomiting	Gastrointestinal disorders	Placebo	7	214
other	Vomiting	Gastrointestinal disorders	Lubiprostone	12	223
serious	Irritable bowel syndrome	Gastrointestinal disorders	Placebo	0	214
serious	Irritable bowel syndrome	Gastrointestinal disorders	Lubiprostone	1	223

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Lubiprostone
Total, other adverse events	Placebo	36	214
Total, other adverse events	Lubiprostone	49	223
Total, serious adverse events	Placebo	7	214
Total, serious adverse events	Lubiprostone	7	223

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 vs Placebo: Responder Rate	Trial comparisons
Lubiprostone 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.

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