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NCT00645801 · ClinicalTrials.gov registry record · Phase 4
Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
A Phase 4 study, sponsored by Henry Ford Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 158
- Enrollment target
NCT00645801: Completed Phase 4 study, sponsored by Henry Ford Health System.
NCT00645801 is a Phase 4 study that has completed, run by Henry Ford Health System. The registered enrollment target is 158 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645801, a Phase 4 study, has completed, sponsored by Henry Ford Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 158 participants
- Enrollment target
Study Summary
The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see the colon better during the colonoscopy to identify abnormal growths such as polyps or colon cancer. Colonoscopy is considered the best way to screen for colon cancer screening because you can visualize the colon directly and remove or biopsy abnormal growths. The limiting step in the procedure is the quality of the colon preparation prior to the procedure. Many patients do not tolerate large volumes of liquid used to prepare the colon. The purpose of the study is to improve the quality of the prep by adding a pill laxative medication before starting the large volume laxative to better see the colon. The other aim of the study is to try to reduce the amount of of liquid laxative the patient has to drink by giving a pill laxative before starting the liquid laxative.
Primary Outcome
Endoscopists evaluated the quality of the colonoscopy preparation based on Ottawa bowel preparation scale. . The total score ranges from 0-14; score of 0 being perfect and score of 14 indicating solid stool in each colon segment and lot of fluid. Before using the scale for this trial, the endoscopists participated in a calibration exercise that involved 20 patients to ensure that they concurred on their interpretation of the scale.
Interventions
- DRUG Placebo
- DRUG lubiprostone (Amitiza)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2008-03 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT00645801 record still lists
NCT00645801 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00645801 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00645801 about?
NCT00645801 is a clinical study titled "Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation". The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for...
What is the current status of trial NCT00645801?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 158 participants. The study started on 2008-03. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00645801?
The interventions under investigation include: Placebo (DRUG), lubiprostone (Amitiza) (DRUG).
Who is sponsoring clinical trial NCT00645801?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645801's enrollment target sits among peer trials
158 516th of 2000 higher than 1,482 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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