Trial · NCT01236534
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
NCT01236534, Phase 4, Completed, University of Rochester; results first posted 2015-12-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lubiprostone in Patients With Multiple Sclerosis Associated Constipation. Trials, record NCT01236534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01236534
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
- NCT number
- NCT01236534
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 21 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Multiple Sclerosis, Constipation
- Interventions
- Lubiprostone, Placebo
- First posted
- 2010-11-08
- Last updated
- 2015-12-10
- Results first posted
- 2015-12-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | 21 days | Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients. |
| Secondary | Number of Participants With Diarrheic Events. | 21 days | To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | 21 days | per protocol | spontaneous bowel movements | MEAN |
| SECONDARY | Number of Participants With Diarrheic Events. | 21 days | per protocol | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | Lubiprostone | 3.4 | Standard Deviation 0.7 | spontaneous bowel movements | |
| Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. | Sugar Pill | 3.2 | Standard Deviation 0.6 | spontaneous bowel movements | |
| Number of Participants With Diarrheic Events. | Lubiprostone | 8 | participants | ||
| Number of Participants With Diarrheic Events. | Sugar Pill | 2 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lubiprostone | 11 | |
| Overall Study | STARTED | Sugar Pill | 10 | |
| Overall Study | COMPLETED | Lubiprostone | 8 | |
| Overall Study | COMPLETED | Sugar Pill | 10 | |
| Overall Study | NOT COMPLETED | Lubiprostone | 3 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | diarrhea | Gastrointestinal disorders | Lubiprostone | 8 | 11 | 8 |
| other | diarrhea | Gastrointestinal disorders | Sugar Pill | 2 | 10 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lubiprostone | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Lubiprostone | 8 | 11 |
| Total, other adverse events | Sugar Pill | 2 | 10 |
| Total, serious adverse events | Lubiprostone | 0 | 11 |
| Total, serious adverse events | Sugar Pill | 0 | 10 |
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 Sugar Pill: Number of Participants With Diarrheic Events. | Trial comparisons |
| Lubiprostone vs Sugar Pill: 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/NCT01236534
GET https://conductscience.org/api/trials/v1/NCT01236534/registered