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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 is a Phase 4 study that has completed, run by Henry Ford Health System. The registered enrollment target is 158 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00645801
The ClinicalTrials.gov registry entry for NCT00645801 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00645801 reports 0 study locations.
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.
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