Trial · NCT01147926
Evaluation of Prucalopride in Male Subjects With Chronic Constipation.
NCT01147926, Phase 3, Completed, Shire; results first posted 2014-09-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Prucalopride in Male Subjects With Chronic Constipation. Trials, record NCT01147926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01147926
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Prucalopride in Male Subjects With Chronic Constipation.
- NCT number
- NCT01147926
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 374 participants, actual
- Lead sponsor
- Shire
- Conditions
- Male Subjects With Chronic Constipation
- Interventions
- Placebo, Prucalopride
- First posted
- 2010-06-22
- Last updated
- 2021-06-10
- Other registries' IDs
- eudract:2009-015719-42
- Results first posted
- 2014-09-09
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week | Over 12 week treatment period | Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. |
| Secondary | Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period | Over 12 week treatment period | |
| Secondary | Percentage of Subjects With an Increase of at Least 1 SCBM Per Week | Over 12 week treatment period | |
| Secondary | SCBM Per Week | Over 12 week treatment period | |
| Secondary | Percent SBM With a Consistency of Normal and Hard/Very Hard | Over 12 week treatment period | Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea. |
| Secondary | Percent SCBM With No Straining and Severe/Very Severe Straining | Over 12 week treatment period | Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe) |
| Secondary | Percent SBM With Sensation of Complete Evacuation | Over 12 week treatment period | |
| Secondary | Time to First SCBM After Investigational Product Intake on Day 1 | Day 1 | |
| Secondary | Bisacodyl Tablets Taken Per Week | Over 12 week treatment period | |
| Secondary | Days With Rescue Medication Taken Per Week | Over 12 week treatment period |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week | Over 12 week treatment period | Modified Intent-to-treat Population (mITT) included all subjects randomized into the study except those excluded due to a major good clinical practice (GCP) breach at one site, who took at least 1 dose of the investigational product. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period | Over 12 week treatment period | mITT | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With an Increase of at Least 1 SCBM Per Week | Over 12 week treatment period | mITT | percentage of subjects | NUMBER |
| SECONDARY | SCBM Per Week | Over 12 week treatment period | mITT. Not all subjects in the mITT population had data for this outcome. | SCBM/week | MEAN |
| SECONDARY | Percent SBM With a Consistency of Normal and Hard/Very Hard | Over 12 week treatment period | mITT. Not all subjects in the mITT population had data for this outcome. | percentage of SBM | MEAN |
| SECONDARY | Percent SCBM With No Straining and Severe/Very Severe Straining | Over 12 week treatment period | mITT. Not all subjects in the mITT population had data for this outcome. | percentage of SBM | MEAN |
| SECONDARY | Percent SBM With Sensation of Complete Evacuation | Over 12 week treatment period | mITT. Not all subjects in the mITT population had data for this outcome. | percentage of SBM | MEAN |
| SECONDARY | Time to First SCBM After Investigational Product Intake on Day 1 | Day 1 | mITT. | hours | MEDIAN |
| SECONDARY | Bisacodyl Tablets Taken Per Week | Over 12 week treatment period | mITT. Not all subjects in the mITT population had data for this outcome. | Tablets/week | MEAN |
| SECONDARY | Days With Rescue Medication Taken Per Week | Over 12 week treatment period | mITT. Not all subjects in the mITT population had data for this outcome. | Days/week | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week | PLACEBO | 17.7 | percentage of subjects | ||
| The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week | PRUCALOPRIDE | 37.9 | percentage of subjects | ||
Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period | PLACEBO | 12.2 | percentage of subjects | ||
Percentage of Subjects With an Average Weekly Frequency of at Least 3 SCBM Per Week and an Increase of ≥ 1 SCBM Per Week for ≥ 75% of the 12-week Treatment Period and ≥ 75% of the Last Third of the 12-week Treatment Period | PRUCALOPRIDE | 27.7 | percentage of subjects | ||
| Percentage of Subjects With an Increase of at Least 1 SCBM Per Week | PLACEBO | 45.3 | percentage of subjects | ||
| Percentage of Subjects With an Increase of at Least 1 SCBM Per Week | PRUCALOPRIDE | 53.7 | percentage of subjects | ||
| SCBM Per Week | PLACEBO | 1.8 | Standard Deviation 1.91 | SCBM/week | |
| SCBM Per Week | PRUCALOPRIDE | 2.6 | Standard Deviation 2.40 | SCBM/week | |
| Percent SBM With a Consistency of Normal and Hard/Very Hard | PLACEBO | Normal consistency | 50.8 | Standard Deviation 30.21 | percentage of SBM |
| Percent SBM With a Consistency of Normal and Hard/Very Hard | PRUCALOPRIDE | Normal consistency | 47.5 | Standard Deviation 31.70 | percentage of SBM |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PLACEBO | 187 | |
| Overall Study | STARTED | PRUCALOPRIDE | 187 | |
| Overall Study | COMPLETED | PLACEBO | 160 | |
| Overall Study | COMPLETED | PRUCALOPRIDE | 158 | |
| Overall Study | NOT COMPLETED | PLACEBO | 27 | |
| Overall Study | NOT COMPLETED | PRUCALOPRIDE | 29 |
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 | ABDOMINAL PAIN | Gastrointestinal disorders | PLACEBO | 11 | 186 | 12 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | PRUCALOPRIDE | 8 | 184 | 11 |
| other | DIARRHOEA | Gastrointestinal disorders | PLACEBO | 3 | 186 | 3 |
| other | DIARRHOEA | Gastrointestinal disorders | PRUCALOPRIDE | 12 | 184 | 16 |
| other | NAUSEA | Gastrointestinal disorders | PLACEBO | 4 | 186 | 4 |
| other | NAUSEA | Gastrointestinal disorders | PRUCALOPRIDE | 11 | 184 | 12 |
| other | HEADACHE | Nervous system disorders | PLACEBO | 7 | 186 | 8 |
| other | HEADACHE | Nervous system disorders | PRUCALOPRIDE | 17 | 184 | 18 |
| serious | ATRIAL FIBRILLATION | Cardiac disorders | PLACEBO | 0 | 186 | 0 |
| serious | ATRIAL FIBRILLATION | Cardiac disorders | PRUCALOPRIDE | 1 | 184 | 1 |
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 | PLACEBO | ||
| Total, all-cause mortality | PRUCALOPRIDE | ||
| Total, other adverse events | PLACEBO | 21 | 186 |
| Total, other adverse events | PRUCALOPRIDE | 37 | 184 |
| Total, serious adverse events | PLACEBO | 4 | 186 |
| Total, serious adverse events | PRUCALOPRIDE | 1 | 184 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PRUCALOPRIDE vs PLACEBO: serious adverse events |
Source 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/NCT01147926
GET https://conductscience.org/api/trials/v1/NCT01147926/results?page=2