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NCT00688662 · ClinicalTrials.gov registry record · NA
Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction
A NA study of Sphincter of Oddi Dysfunction, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 214
- Enrollment target
- 7
- Study locations
NCT00688662: Completed NA study of Sphincter of Oddi Dysfunction, sponsored by Medical University of South Carolina.
NCT00688662 is a NA study of Sphincter of Oddi Dysfunction that has completed, run by Medical University of South Carolina. The registered enrollment target is 214 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00688662, a NA study of Sphincter of Oddi Dysfunction, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 214 participants
- Enrollment target
- 7
- Study locations
Study Summary
The Evaluating Predictors \& Interventions in Sphincter of Oddi Dysfunction(SOD) study (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of Oddi dysfunction type III.
Primary Outcome
The primary outcome was a dichotomous (success/failure) variable. Success was defined as patients having a RAPID score of \<6 days at months 9 and 12 post-procedure, without re-intervention and without use of prescription analgesics during months 10, 11 and 12 unless used for non-abdominal pain for no more than 14 days. The subject was considered a failure if the 12-month RAPID score was missing or collected outside the acceptable window. If the 9-month RAPID was missing, or outside of the windo
Conditions Studied
Interventions
- PROCEDURE ERCP with sphincterotomy
- PROCEDURE ERCP without sphincterotomy
Study Locations (7)
Connecticut
- Yale University - New Haven
Indiana
- Indiana University - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Midwest Therapeutic Endoscopy Consultants - St Louis
South Carolina
- Medical University of South Carolina Digestive Disease Center - Charleston
Texas
- Methodist Dallas Medical Center - Dallas
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2008-07 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT00688662 record still lists
NCT00688662 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Sphincter of Oddi Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which ERCP with sphincterotomy is the first listed.
NCT00688662 lists 7 locations in 7 states (Connecticut, Indiana, Minnesota).
Frequently Asked Questions
What is clinical trial NCT00688662 about?
NCT00688662 is a clinical study titled "Evaluating Predictors & Interventions in Sphincter of Oddi Dysfunction". The Evaluating Predictors \& Interventions in Sphincter of Oddi Dysfunction(SOD) study (EPISOD) is a randomized sham-controlled study of biliary and pancreatic sphincterotomy as treatment for patients with pain after cholecystectomy fitting the criteria for sphincter of Oddi dysfunction type III.
What is the current status of trial NCT00688662?
This trial is currently completed. It is a NA study. The enrollment target is 214 participants. The study started on 2008-07. Estimated completion is 2016-12.
What conditions does trial NCT00688662 study?
This clinical trial studies the following conditions: Sphincter of Oddi Dysfunction.
What interventions are being tested in trial NCT00688662?
The interventions under investigation include: ERCP with sphincterotomy (PROCEDURE), ERCP without sphincterotomy (PROCEDURE).
Who is sponsoring clinical trial NCT00688662?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00688662 being conducted?
This trial has 7 study locations across Connecticut, Indiana, Minnesota, Missouri, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00688662's enrollment target sits among peer trials
214 487th of 2000 higher than 1,513 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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