Trial · NCT01096290
Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
NCT01096290, Phase 4, Terminated, University of South Alabama; results first posted 2020-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications. Trials, record NCT01096290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01096290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
- NCT number
- NCT01096290
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 23 participants, actual
- Lead sponsor
- University of South Alabama
- Conditions
- Constipation
- Interventions
- lubiprostone, Matched placebo
- First posted
- 2010-03-31
- Last updated
- 2020-11-20
- Results first posted
- 2020-09-09
- Limitations and caveats
100 participants were needed to obtain statistical power. Only 23 participants were enrolled. Therefore, data analysis was not completed since a success rate could not be adequately demonstrated on such a small sample.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relief of Constipation Defined by Modified ROME Criteria | 30 days | Subjects will report symptoms by questionnaire |
| Secondary | Frequency | 30 days | Subjects will report stool frequency by questionnaire |
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 | Relief of Constipation Defined by Modified ROME Criteria | 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency | 30 days | Data was not collected for this Outcome Measure |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relief of Constipation Defined by Modified ROME Criteria | Lubiprostone 24mcg BID for 30 Days | 7 | Participants | ||
| Relief of Constipation Defined by Modified ROME Criteria | Placebo | 7 | 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 24mcg BID for 30 Days | 9 | |
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | COMPLETED | Lubiprostone 24mcg BID for 30 Days | 9 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Lubiprostone 24mcg BID for 30 Days | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lubiprostone 24mcg BID for 30 Days | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, other adverse events | Lubiprostone 24mcg BID for 30 Days | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 14 |
| Total, serious adverse events | Lubiprostone 24mcg BID for 30 Days | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 14 |
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 24mcg BID for 30 Days vs Placebo: Relief of Constipation Defined by Modified ROME Criteria | Trial comparisons |
| Lubiprostone 24mcg BID for 30 Days vs Placebo: deaths from any cause | Trial comparisons |
| Lubiprostone 24mcg BID for 30 Days 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/NCT01096290
GET https://conductscience.org/api/trials/v1/NCT01096290/registered