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NCT01073930 · ClinicalTrials.gov registry record · Phase 3
Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
A Phase 3 study of Bowel Preparation, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
- 9
- Study locations
NCT01073930: Completed Phase 3 study of Bowel Preparation, sponsored by Ferring Pharmaceuticals.
NCT01073930 is a Phase 3 study of Bowel Preparation that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 608 participants, below the 857-participant average among 3 other Bowel Preparation trials with a reported enrollment target (29% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01073930, a Phase 3 study of Bowel Preparation, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
- 9
- Study locations
Study Summary
Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.
Primary Outcome
Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as \>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as \>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
Conditions Studied
Interventions
- DRUG PicoPrep
- DRUG HalfLytely
- DRUG bisacodyl
Study Locations (9)
Alabama
- Clinical Research Associates - Huntsville
Arkansas
- Arkansas Gastroenterology - Sherwood
Connecticut
- Connecticut Gastroenterology Institute - Bristol
Indiana
- Indiana University Hospital - Indianapolis
Louisiana
- Louisiana Research Center LLC - Shreveport
North Carolina
- Piedmont Medical Research Associates - Winston-Salem
Pennsylvania
- Hillmont GI, P.C. - Flourtown
Tennessee
- ClinSearch - Chattanooga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT01073930 record still lists
NCT01073930 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, below the 857-participant average among 3 other Bowel Preparation trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Bowel Preparation appearing as the primary indexed condition, and to 3 interventions - of which PicoPrep is the first listed.
NCT01073930 lists 9 locations in 9 states (Alabama, Arkansas, Connecticut).
Frequently Asked Questions
What is clinical trial NCT01073930 about?
NCT01073930 is a clinical study titled "Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep". Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bi...
What is the current status of trial NCT01073930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2010-05. Estimated completion is 2010-10.
What conditions does trial NCT01073930 study?
This clinical trial studies the following conditions: Bowel Preparation.
What interventions are being tested in trial NCT01073930?
The interventions under investigation include: PicoPrep (DRUG), HalfLytely (DRUG), bisacodyl (DRUG).
Who is sponsoring clinical trial NCT01073930?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01073930 being conducted?
This trial has 9 study locations across Alabama, Arkansas, Connecticut, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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