Trial · NCT02544152
Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
NCT02544152, Phase 2, Terminated, Sucampo Pharma Americas, LLC; results first posted 2019-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome. Trials, record NCT02544152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02544152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
- NCT number
- NCT02544152
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Sucampo Pharma Americas, LLC
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Lubiprostone, Placebo
- First posted
- 2015-09-09
- Last updated
- 2019-12-27
- Results first posted
- 2019-12-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Classified as an Overall Responder for Abdominal Pain | within 12 weeks | An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks. |
| Secondary | Number of Participants Classified as a Weekly Responder for Abdominal Pain | within 12 weeks | Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse. A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week. |
| Secondary | Number of Participants Classified as a Monthly Responder for Abdominal Pain | within 3 months | A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month. |
| Secondary | Number of Participants Classified as a Weekly Responder for Stool Consistency | within 12 weeks | A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week. |
| Secondary | Number of Participants Classified as a Monthly Responder for Stool Consistency | within 3 months | A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month. |
| Secondary | Number of Participants Classified as an Overall Responder for Stool Consistency | within 3 months | An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks. |
| Secondary | Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms | within 12 weeks | A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms. |
| Secondary | Number of Participants Classified as a Monthly Responder for IBS Symptoms | within 3 months | A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms. |
| Secondary | Number of Participants Classified as an Overall Responder for IBS Symptoms | within 3 months | A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms. |
Source ClinicalTrials.gov
Outcomes9
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 an Overall Responder for Abdominal Pain | within 12 weeks | modified Intent to Treat (mITT), defined as all randomized subjects who take at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as a Weekly Responder for Abdominal Pain | within 12 weeks | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as a Monthly Responder for Abdominal Pain | within 3 months | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as a Weekly Responder for Stool Consistency | within 12 weeks | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as a Monthly Responder for Stool Consistency | within 3 months | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as an Overall Responder for Stool Consistency | within 3 months | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms | within 12 weeks | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as a Monthly Responder for IBS Symptoms | within 3 months | mITT | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Classified as an Overall Responder for IBS Symptoms | within 3 months | mITT | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group96
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 an Overall Responder for Abdominal Pain | Placebo | 10 | Participants | ||
| Number of Participants Classified as an Overall Responder for Abdominal Pain | Lubiprostone | 11 | Participants | ||
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Placebo | Week 1 | 7 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Lubiprostone | Week 1 | 7 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Placebo | Week 2 | 13 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Lubiprostone | Week 2 | 8 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Placebo | Week 3 | 11 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Lubiprostone | Week 3 | 12 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Placebo | Week 4 | 13 | Participants | |
| Number of Participants Classified as a Weekly Responder for Abdominal Pain | Lubiprostone | Week 4 | 19 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 34 | |
| Overall Study | STARTED | Lubiprostone | 37 | |
| Overall Study | Modified Intent to Treat (mITT) | Placebo | 34 | |
| Overall Study | Modified Intent to Treat (mITT) | Lubiprostone | 37 | |
| Overall Study | Safety Analysis Set (SAS) | Placebo | 34 | |
| Overall Study | Safety Analysis Set (SAS) | Lubiprostone | 37 | |
| Overall Study | COMPLETED | Placebo | 33 | |
| Overall Study | COMPLETED | Lubiprostone | 30 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Lubiprostone | 7 |
Source ClinicalTrials.gov
Adverse events44
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 | Events |
|---|---|---|---|---|---|---|
| other | Diabetic retinal oedema | Endocrine disorders | Placebo | 1 | 34 | |
| other | Diabetic retinal oedema | Endocrine disorders | Lubiprostone | 0 | 37 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 34 | |
| other | Nausea | Gastrointestinal disorders | Lubiprostone | 2 | 37 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 34 | |
| other | Abdominal pain | Gastrointestinal disorders | Lubiprostone | 1 | 37 | |
| other | Colitis | Gastrointestinal disorders | Placebo | 0 | 34 | |
| other | Colitis | Gastrointestinal disorders | Lubiprostone | 1 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 34 | |
| other | Diarrhoea | Gastrointestinal disorders | Lubiprostone | 1 | 37 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 34 |
| Total, all-cause mortality | Lubiprostone | 0 | 37 |
| Total, other adverse events | Placebo | 8 | 34 |
| Total, other adverse events | Lubiprostone | 12 | 37 |
| Total, serious adverse events | Placebo | 0 | 34 |
| Total, serious adverse events | Lubiprostone | 1 | 37 |
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 comparisons5
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 an Overall Responder for Stool Consistency | Trial comparisons |
| Lubiprostone vs Placebo: Number of Participants Classified as an Overall Responder for IBS Symptoms | Trial comparisons |
| Lubiprostone vs Placebo: Number of Participants Classified as an Overall Responder for Abdominal Pain | 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.
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/NCT02544152
GET https://conductscience.org/api/trials/v1/NCT02544152/results?page=2