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NCT03198221 · ClinicalTrials.gov registry record · Phase 4
Comparison of Clenpiq vs Golytely Bowel Preparation
A Phase 4 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT03198221: Clinical Trial Phase 4 study, sponsored by The Cleveland Clinic.
NCT03198221 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03198221, a Phase 4 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the standard of care (4 Liter polyethylene glycol based preparation) or a low volume bowel preparation (sodium picosulfate, a stimulant laxative, magnesium oxide and anhydrous citric acid (SP/MC)). Both agents will either be administered as full dose the evening before or as split-dose on the evening before and on the day of the procedure.
Primary Outcome
Bowel cleansing efficacy will be measured using the Boston Bowel Prep Scale (BBPS). The BBPS divides the colon into 3 segments (right, transverse, left); each is scored from 0-3 (0=colonic mucosa not seen due to solid stool that cannot be cleared, 1=only a portion of the mucosa of the colon segment is seen due to staining, residual stool and/or opaque liquid, 2=minor amount of residual staining, small fragments of stool and/or opaque liquid but mucosa of colon segment is seen well, and 3=entire
Interventions
- DRUG Golytely
- DRUG Clenpiq
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-07-11 |
| Est. Completion | 2019-03-26 |
| Phase | Phase 4 |
Why NCT03198221 stopped before completion
NCT03198221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Golytely is the first listed.
NCT03198221 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03198221 about?
NCT03198221 is a clinical study titled "Comparison of Clenpiq vs Golytely Bowel Preparation". This is a prospective randomized study which will be done at main campus Cleveland Clinic. The investigators will be comparing the colon cleansing by the Boston Bowel Preparation Scale in participants undergoing colonoscopy as an inpatient at our hospital. Participants will be randomized to the the ...
What is the current status of trial NCT03198221?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2018-07-11. Estimated completion is 2019-03-26.
What interventions are being tested in trial NCT03198221?
The interventions under investigation include: Golytely (DRUG), Clenpiq (DRUG).
Who is sponsoring clinical trial NCT03198221?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03198221's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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