Trial · NCT01993875
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
NCT01993875, Phase 3, Completed, Mallinckrodt; results first posted 2019-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation. Trials, record NCT01993875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01993875
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
- NCT number
- NCT01993875
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 164 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Lubiprostone, Placebo
- First posted
- 2013-11-25
- Last updated
- 2019-12-13
- Results first posted
- 2019-12-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Spontaneous Bowel Movements (SBMs) Within 1 Week | within 1 week | SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. |
| Secondary | Consistency of SBMs at Week 1 | at Week 1 | Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. |
| Secondary | Overall Stool Consistency at Week 1 | at Week 1 | Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. |
| Secondary | Mean Change From Baseline in Stool Consistency at Week 1 | Baseline and Week 1 | Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean). |
| Secondary | Overall Straining at Week 1 | Week 1 | Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). |
| Secondary | Mean Change From Baseline in Straining at Week 1 | Week 1 | Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value. |
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 | Number of Spontaneous Bowel Movements (SBMs) Within 1 Week | within 1 week | Modified Intention to Treat (mITT), defined as all participants who received at least 1 dose of study medication. | number of SBMs | MEAN |
| SECONDARY | Consistency of SBMs at Week 1 | at Week 1 | mITT Population | score on a scale | MEAN |
| SECONDARY | Overall Stool Consistency at Week 1 | at Week 1 | mITT Population | score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Stool Consistency at Week 1 | Baseline and Week 1 | mITT Population | Units on a scale | MEAN |
| SECONDARY | Overall Straining at Week 1 | Week 1 | mITT Population | Units on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Straining at Week 1 | Week 1 | mITT Population | Units on a scale | 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 Spontaneous Bowel Movements (SBMs) Within 1 Week | Lubiprostone | 4.6 | Standard Deviation 3.33 | number of SBMs | |
| Number of Spontaneous Bowel Movements (SBMs) Within 1 Week | Placebo | 4.0 | Standard Deviation 3.50 | number of SBMs | |
| Consistency of SBMs at Week 1 | Lubiprostone | 3.2 | Standard Deviation 3.12 | score on a scale | |
| Consistency of SBMs at Week 1 | Placebo | 2.4 | Standard Deviation 3.38 | score on a scale | |
| Overall Stool Consistency at Week 1 | Lubiprostone | 3.3 | Standard Deviation 1.38 | score on a scale | |
| Overall Stool Consistency at Week 1 | Placebo | 3.0 | Standard Deviation 1.17 | score on a scale | |
| Mean Change From Baseline in Stool Consistency at Week 1 | Lubiprostone | 1.8 | Standard Deviation 0.91 | Units on a scale | |
| Mean Change From Baseline in Stool Consistency at Week 1 | Placebo | 1.9 | Standard Deviation 0.81 | Units on a scale | |
| Overall Straining at Week 1 | Lubiprostone | 1.8 | Standard Deviation 0.91 | Units on a scale | |
| Overall Straining at Week 1 | Placebo | 1.9 | Standard Deviation 0.81 | Units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lubiprostone | 82 | |
| Overall Study | STARTED | Placebo | 82 | |
| Overall Study | COMPLETED | Lubiprostone | 75 | |
| Overall Study | COMPLETED | Placebo | 76 | |
| Overall Study | NOT COMPLETED | Lubiprostone | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events18
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 | Nausea | Gastrointestinal disorders | Lubiprostone | 9 | 82 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 82 | |
| other | Flatulence | Gastrointestinal disorders | Lubiprostone | 7 | 82 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 6 | 82 | |
| other | Abdominal distension | Gastrointestinal disorders | Lubiprostone | 1 | 82 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 3 | 82 | |
| other | Abdominal pain | Gastrointestinal disorders | Lubiprostone | 1 | 82 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 3 | 82 | |
| other | Upper respiratory tract infection | Infections and infestations | Lubiprostone | 2 | 82 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 0 | 82 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lubiprostone | 0 | 82 |
| Total, all-cause mortality | Placebo | 0 | 82 |
| Total, other adverse events | Lubiprostone | 21 | 82 |
| Total, other adverse events | Placebo | 15 | 82 |
| Total, serious adverse events | Lubiprostone | 0 | 82 |
| Total, serious adverse events | Placebo | 0 | 82 |
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: 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/NCT01993875
GET https://conductscience.org/api/trials/v1/NCT01993875/registered