Trial · NCT01732692
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
NCT01732692, Phase 3, Completed, Takeda; results first posted 2014-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation. Trials, record NCT01732692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01732692
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
- NCT number
- NCT01732692
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 140 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
- Interventions
- MOVIPREP
- First posted
- 2012-11-26
- Last updated
- 2014-05-15
- Results first posted
- 2014-05-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Successful Colon Cleansing | 1 day (the day of colonoscopy) | Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В. |
| Secondary | Patient Satisfaction of Colonoscopy Preparation (VAS) | 1 day (the day of colonoscopy) | Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as "totally unacceptable" (lowest patient satisfaction of colonoscopy preparation) and 100 is "fully acceptable" (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant. |
| Secondary | Total Compliance Score | 1 day (the day of colonoscopy) | Compliance score = 100 \* (total amount MOVIPREP® intake) / (planned MOVIPREP intake). Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre. |
| Secondary | Patient Compliance - Amount of Additional Clear Liquid Consumed | 1 day (the day of colonoscopy) | To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken. |
| Secondary | Percentage of Patients Who Experienced Adverse Events (AEs) | From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. | An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Successful Colon Cleansing | 1 day (the day of colonoscopy) | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Patient Satisfaction of Colonoscopy Preparation (VAS) | 1 day (the day of colonoscopy) | Intent-to-treat population with available VAS data. | units on a scale | MEAN |
| SECONDARY | Total Compliance Score | 1 day (the day of colonoscopy) | Intent-to-treat with available data | units on a scale | MEAN |
| SECONDARY | Patient Compliance - Amount of Additional Clear Liquid Consumed | 1 day (the day of colonoscopy) | Intent-to-treat population with available data | ml | MEAN |
| SECONDARY | Percentage of Patients Who Experienced Adverse Events (AEs) | From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours. | Safety population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Successful Colon Cleansing | MOVIPREP (Morning-only Dose) | 94.29 | percentage of participants | ||
| Percentage of Participants With Successful Colon Cleansing | MOVIPREP (Split-dose) | 91.43 | percentage of participants | ||
| Patient Satisfaction of Colonoscopy Preparation (VAS) | MOVIPREP (Morning-only Dose) | 81.2 | Standard Deviation 20.97 | units on a scale | |
| Patient Satisfaction of Colonoscopy Preparation (VAS) | MOVIPREP (Split-dose) | 79.6 | Standard Deviation 23.18 | units on a scale | |
| Total Compliance Score | MOVIPREP (Morning-only Dose) | 98.1 | Standard Deviation 6.10 | units on a scale | |
| Total Compliance Score | MOVIPREP (Split-dose) | 99.5 | Standard Deviation 2.66 | units on a scale | |
| Patient Compliance - Amount of Additional Clear Liquid Consumed | MOVIPREP (Morning-only Dose) | After first liter of study drug | 545.43 | Standard Deviation 128.6 | ml |
| Patient Compliance - Amount of Additional Clear Liquid Consumed | MOVIPREP (Split-dose) | After first liter of study drug | 640.29 | Standard Deviation 243.4 | ml |
| Patient Compliance - Amount of Additional Clear Liquid Consumed | MOVIPREP (Morning-only Dose) | After second liter of study drug | 539.71 | Standard Deviation 116.5 | ml |
| Patient Compliance - Amount of Additional Clear Liquid Consumed | MOVIPREP (Split-dose) | After second liter of study drug | 585.65 | Standard Deviation 145.2 | ml |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MOVIPREP (Morning-only Dose) | 70 | |
| Overall Study | STARTED | MOVIPREP (Split-dose) | 70 | |
| Overall Study | COMPLETED | MOVIPREP (Morning-only Dose) | 70 | |
| Overall Study | COMPLETED | MOVIPREP (Split-dose) | 69 | |
| Overall Study | NOT COMPLETED | MOVIPREP (Morning-only Dose) | 0 | |
| Overall Study | NOT COMPLETED | MOVIPREP (Split-dose) | 1 |
Source ClinicalTrials.gov
Adverse events40
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 discomfort | Gastrointestinal disorders | MOVIPREP (Morning-only Dose) | 13 | 70 | |
| other | Abdominal discomfort | Gastrointestinal disorders | MOVIPREP (Split-dose) | 26 | 70 | |
| other | Abdominal pain | Gastrointestinal disorders | MOVIPREP (Morning-only Dose) | 1 | 70 | |
| other | Abdominal pain | Gastrointestinal disorders | MOVIPREP (Split-dose) | 5 | 70 | |
| other | Abdominal tenderness | Gastrointestinal disorders | MOVIPREP (Morning-only Dose) | 1 | 70 | |
| other | Abdominal tenderness | Gastrointestinal disorders | MOVIPREP (Split-dose) | 2 | 70 | |
| other | Gastritis erosive | Gastrointestinal disorders | MOVIPREP (Morning-only Dose) | 0 | 70 | |
| other | Gastritis erosive | Gastrointestinal disorders | MOVIPREP (Split-dose) | 1 | 70 | |
| other | Nausea | Gastrointestinal disorders | MOVIPREP (Morning-only Dose) | 30 | 70 | |
| other | Nausea | Gastrointestinal disorders | MOVIPREP (Split-dose) | 22 | 70 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MOVIPREP (Morning-only Dose) | ||
| Total, all-cause mortality | MOVIPREP (Split-dose) | ||
| Total, other adverse events | MOVIPREP (Morning-only Dose) | 41 | 70 |
| Total, other adverse events | MOVIPREP (Split-dose) | 43 | 70 |
| Total, serious adverse events | MOVIPREP (Morning-only Dose) | 0 | 70 |
| Total, serious adverse events | MOVIPREP (Split-dose) | 0 | 70 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MOVIPREP (Morning-only Dose) vs MOVIPREP (Split-dose): 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/NCT01732692
GET https://conductscience.org/api/trials/v1/NCT01732692/results?page=2