Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00471315 · ClinicalTrials.gov registry record · Phase 3
Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)
A Phase 3 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT00471315: Completed Phase 3 study, sponsored by Medical University of South Carolina.
NCT00471315 is a Phase 3 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00471315, a Phase 3 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
Open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments. This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
Primary Outcome
The primary outcome measure was a Patient Global Assessment of Change (PGIC) scale which reports the patient's overall view of any changes in their overall status since their sphincterotomy treatment. (1=Very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). Success was defined as 3-month PGIC score of much or very much improved (PGIC of either 1 or 2). Patients missing the 3 month visit were considered failures for the primar
Interventions
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2006-07 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00471315 record still lists
NCT00471315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Duloxetine is the first listed.
NCT00471315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00471315 about?
NCT00471315 is a clinical study titled "Duloxetine in Patients With Suspected Functional Pancreatic/Biliary Pain (Sphincter of Oddi Dysfunction)". Open-label single center study of duloxetine in patients with SOD who have failed to respond to the standard treatments. This protocol is designed to explore the tolerability and efficacy of Duloxetine in the management of patients with known or suspected Sphincter of Oddi dysfunction (SOD).
What is the current status of trial NCT00471315?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2006-07. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00471315?
The interventions under investigation include: Duloxetine (DRUG).
Who is sponsoring clinical trial NCT00471315?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00471315's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia