Trial · NCT01298219

Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

NCT01298219, Phase 3, Completed, Sucampo Pharma Americas, LLC; results first posted 2019-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL). Trials, record NCT01298219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01298219

On this page

Trial

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

Title: Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
NCT number: NCT01298219
Status: Completed
Phases: Phase 3
Enrollment: 439 participants, actual
Lead sponsor: Sucampo Pharma Americas, LLC
Conditions: Opioid-induced Bowel Dysfunction
Interventions: Lubiprostone, Placebo
First posted: 2011-02-17
Last updated: 2020-02-11
Results first posted: 2019-12-24

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Participants Classified as Treatment Responders Within 12 Weeks	12 weeks	Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
Secondary	Number of SBMs Per Week at Week 8	at Week 8
Secondary	Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	within 48 hours post-dose
Secondary	Number of SBMs Per Week at Week 12	at Week 12
Secondary	Number of SBMs Per Week Overall	within 14 weeks	Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Classified as Treatment Responders Within 12 Weeks	12 weeks	Intention to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of SBMs Per Week at Week 8	at Week 8	Intention to treat with data at Week 8	SBMs/week	MEAN
SECONDARY	Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	within 48 hours post-dose	Intention to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of SBMs Per Week at Week 12	at Week 12	Intention to treat with data at Week 12	SBMs/week	MEAN
SECONDARY	Number of SBMs Per Week Overall	within 14 weeks	Intention to treat with data at Week 14	SBMs/week	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants Classified as Treatment Responders Within 12 Weeks	Lubiprostone		59		Participants
Number of Participants Classified as Treatment Responders Within 12 Weeks	Placebo		41		Participants
Number of SBMs Per Week at Week 8	Lubiprostone		2.9	Standard Deviation 3.18	SBMs/week
Number of SBMs Per Week at Week 8	Placebo		2.5	Standard Deviation 3.03	SBMs/week
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	Lubiprostone	within 24 Hours	110		Participants
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	Placebo	within 24 Hours	84		Participants
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	Lubiprostone	within 48 Hours	157		Participants
Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	Placebo	within 48 Hours	134		Participants
Number of SBMs Per Week at Week 12	Lubiprostone		3.1	Standard Deviation 3.13	SBMs/week
Number of SBMs Per Week at Week 12	Placebo		2.7	Standard Deviation 3.34	SBMs/week

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Lubiprostone	219
Overall Study	STARTED	Placebo	220
Overall Study	Intention to Treat (ITT)	Lubiprostone	219
Overall Study	Intention to Treat (ITT)	Placebo	220
Overall Study	Safety Analysis Set	Lubiprostone	219
Overall Study	Safety Analysis Set	Placebo	220
Overall Study	COMPLETED	Lubiprostone	169
Overall Study	COMPLETED	Placebo	184
Overall Study	NOT COMPLETED	Lubiprostone	50
Overall Study	NOT COMPLETED	Placebo	36

Source ClinicalTrials.gov

Adverse events56

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	Lubiprostone	24	219
other	Diarrhea	Gastrointestinal disorders	Placebo	8	220
other	Nausea	Gastrointestinal disorders	Lubiprostone	21	219
other	Nausea	Gastrointestinal disorders	Placebo	10	220
other	Vomiting	Gastrointestinal disorders	Lubiprostone	9	219
other	Vomiting	Gastrointestinal disorders	Placebo	11	220
other	Abdominal Pain	Gastrointestinal disorders	Lubiprostone	15	219
other	Abdominal Pain	Gastrointestinal disorders	Placebo	0	220
other	Flatulence	Gastrointestinal disorders	Lubiprostone	6	219
other	Flatulence	Gastrointestinal disorders	Placebo	5	220

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lubiprostone	1	219
Total, all-cause mortality	Placebo	0	220
Total, other adverse events	Lubiprostone	72	219
Total, other adverse events	Placebo	44	220
Total, serious adverse events	Lubiprostone	7	219
Total, serious adverse events	Placebo	6	220

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 comparisons3

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

Comparison	Source
Lubiprostone vs Placebo: Number of Participants Classified as Treatment Responders Within 12 Weeks	Trial comparisons
Lubiprostone vs Placebo: deaths from any cause	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.

GET https://conductscience.org/api/trials/v1/NCT01298219

GET https://conductscience.org/api/trials/v1/NCT01298219/events?page=2

API reference For AI assistants