Trial · NCT01427296
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
NCT01427296, Phase 4, Completed, Bausch Health Americas, Inc.; results first posted 2018-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing. Trials, record NCT01427296. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01427296
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
- NCT number
- NCT01427296
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,154 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Colon Cleansing
- Interventions
- Polyethylene glycol, Oral sodium phosphate solution
- First posted
- 2011-09-01
- Last updated
- 2018-01-18
- Results first posted
- 2018-01-18
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | 6 months |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | OsmoPrep Tablets | Excellent | 618 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | HalfLytely and Bisacodyl Tablet | Excellent | 243 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | OsmoPrep Tablets | Good | 275 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | HalfLytely and Bisacodyl Tablet | Good | 423 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | OsmoPrep Tablets | Fair | 116 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | HalfLytely and Bisacodyl Tablet | Fair | 286 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | OsmoPrep Tablets | Inadequate | 23 | Participants | |
| Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. | HalfLytely and Bisacodyl Tablet | Inadequate | 88 | 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 | OsmoPrep Tablets | 1,041 | |
| Overall Study | STARTED | HalfLytely and Bisacodyl Tablet | 1,051 | |
| Overall Study | COMPLETED | OsmoPrep Tablets | 1,041 | |
| Overall Study | COMPLETED | HalfLytely and Bisacodyl Tablet | 1,051 | |
| Overall Study | NOT COMPLETED | OsmoPrep Tablets | 0 | |
| Overall Study | NOT COMPLETED | HalfLytely and Bisacodyl Tablet | 0 |
Source ClinicalTrials.gov
Adverse events146
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 | OsmoPrep Tablets | 12 | 1,041 | |
| other | Abdominal pain | Gastrointestinal disorders | HalfLytely and Bisacodyl Tablet | 21 | 1,051 | |
| other | Constipation | Gastrointestinal disorders | OsmoPrep Tablets | 10 | 1,041 | |
| other | Constipation | Gastrointestinal disorders | HalfLytely and Bisacodyl Tablet | 6 | 1,051 | |
| other | Diarrhea | Gastrointestinal disorders | OsmoPrep Tablets | 10 | 1,041 | |
| other | Diarrhea | Gastrointestinal disorders | HalfLytely and Bisacodyl Tablet | 12 | 1,051 | |
| other | Gastritis | Gastrointestinal disorders | OsmoPrep Tablets | 21 | 1,041 | |
| other | Gastritis | Gastrointestinal disorders | HalfLytely and Bisacodyl Tablet | 11 | 1,051 | |
| other | Nausea | Gastrointestinal disorders | OsmoPrep Tablets | 42 | 1,041 | |
| other | Nausea | Gastrointestinal disorders | HalfLytely and Bisacodyl Tablet | 50 | 1,051 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OsmoPrep Tablets | ||
| Total, all-cause mortality | HalfLytely and Bisacodyl Tablet | ||
| Total, other adverse events | OsmoPrep Tablets | 443 | 1,041 |
| Total, other adverse events | HalfLytely and Bisacodyl Tablet | 352 | 1,051 |
| Total, serious adverse events | OsmoPrep Tablets | 20 | 1,041 |
| Total, serious adverse events | HalfLytely and Bisacodyl Tablet | 19 | 1,051 |
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 |
|---|
| OsmoPrep Tablets vs HalfLytely and Bisacodyl Tablet: 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/NCT01427296
GET https://conductscience.org/api/trials/v1/NCT01427296/events?page=2