Trial · NCT01447849
Lubiprostone and Mucus Secretion in Patients With Chronic Constipation
NCT01447849, Phase 2, Phase 3, Completed, Texas Tech University Health Sciences Center, El Paso; results first posted 2013-09-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lubiprostone and Mucus Secretion in Patients With Chronic Constipation. Trials, record NCT01447849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01447849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lubiprostone and Mucus Secretion in Patients With Chronic Constipation
- NCT number
- NCT01447849
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Conditions
- Constipation
- Interventions
- lubiprostone, placebo
- First posted
- 2011-10-06
- Last updated
- 2017-06-09
- Results first posted
- 2013-09-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between. | The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). |
| Secondary | Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. | Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between. | The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator). |
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 | Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between. | Number of participants was calculated to provide statistical power of 0.80 for detection of significance. | mg/hour | MEAN |
| SECONDARY | Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. | Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between. | To provide 0.80 statistical power for detection of significance. | Centipoises | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Lubiprostone 24 mcg BID | Mucus Secretion in Chronic Constipation Subjects | 260 | Standard Error 29 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Placebo | Mucus Secretion in Chronic Constipation Subjects | 133 | Standard Error 16 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Lubiprostone 24 mcg BID | Mucus Secretion in Controls | 229 | Standard Error 33 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Placebo | Mucus Secretion in Controls | 161 | Standard Error 25 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Lubiprostone 24 mcg BID | Mucin Secretion in Chronic Constipation Subjects | 99 | Standard Error 14 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Placebo | Mucin Secretion in Chronic Constipation Subjects | 54 | Standard Error 7 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Lubiprostone 24 mcg BID | Mucin Secretion in Controls | 100 | Standard Error 16 | mg/hour |
| Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls. | Placebo | Mucin Secretion in Controls | 69 | Standard Error 14 | mg/hour |
| Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. | Lubiprostone 24 mcg Bid | Basal viscosity in chronic constipation subjects | 21.61 | Standard Error 2.95 | Centipoises |
| Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation. | Placebo | Basal viscosity in chronic constipation subjects | 6.34 | Standard Error 1.01 | Centipoises |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo | 10 | |
| First Intervention | STARTED | Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone | 10 | |
| First Intervention | STARTED | Controls on Lubiprostone Then Placebo | 10 | |
| First Intervention | STARTED | Controls on Placebo Then Lubiprostone | 10 | |
| First Intervention | COMPLETED | Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo | 10 | |
| First Intervention | COMPLETED | Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone | 10 | |
| First Intervention | COMPLETED | Controls on Lubiprostone Then Placebo | 10 | |
| First Intervention | COMPLETED | Controls on Placebo Then Lubiprostone | 10 | |
| First Intervention | NOT COMPLETED | Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo | 0 | |
| First Intervention | NOT COMPLETED | Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chronic Constipation Subjects on Lubiprostone Then Placebo | ||
| Total, all-cause mortality | Chronic Constipation Subjects on Placebo Then Lubiprostone | ||
| Total, all-cause mortality | Controls on Lubiprostone Then Placebo | ||
| Total, all-cause mortality | Controls on Placebo Then Lubiprostone | ||
| Total, other adverse events | Chronic Constipation Subjects on Lubiprostone Then Placebo | 0 | 10 |
| Total, other adverse events | Chronic Constipation Subjects on Placebo Then Lubiprostone | 0 | 10 |
| Total, other adverse events | Controls on Lubiprostone Then Placebo | 0 | 10 |
| Total, other adverse events | Controls on Placebo Then Lubiprostone | 0 | 10 |
| Total, serious adverse events | Chronic Constipation Subjects on Lubiprostone Then Placebo | 0 | 10 |
| Total, serious adverse events | Chronic Constipation Subjects on Placebo Then Lubiprostone | 0 | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01447849
GET https://conductscience.org/api/trials/v1/NCT01447849/flow?page=2