Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01214382 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery
A Phase 3 study of Roux en Y Gastric Bypass Surgery, sponsored by North Dakota State University.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01214382: Completed Phase 3 study of Roux en Y Gastric Bypass Surgery, sponsored by North Dakota State University.
NCT01214382 is a Phase 3 study of Roux en Y Gastric Bypass Surgery that has completed, run by North Dakota State University. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01214382, a Phase 3 study of Roux en Y Gastric Bypass Surgery, has completed, sponsored by North Dakota State University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatric surgery, 2) at three months following the surgery, and 3) twelve months following surgery. This study will enroll approximately 30 participants.
Primary Outcome
The primary aim of this research is to provide a prospective, longitudinal comparison of pharmacokinetic measures associated with a single-dose of sertraline in RYGBP patients. Comparisons will be based upon sertraline plasma concentrations obtained prior to surgery and repeated at three and 12 months following surgery. A 24+ month post-surgery follow-up to evaluate sertraline tablet AUC will be offered to a subset of study volunteers.
Conditions Studied
Interventions
- DRUG Sertraline
Study Locations (1)
North Dakota
- Neuropsychiatric Research Institute - Fargo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01214382 record still lists
NCT01214382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Roux en Y Gastric Bypass Surgery appearing as the primary indexed condition, and to 1 intervention - of which Sertraline is the first listed.
NCT01214382 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT01214382 about?
NCT01214382 is a clinical study titled "Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery". This study is being conducted to evaluate how the body absorbs and processes the medication sertraline (Zoloft®) before compared to how it is absorbed at two time points after gastric bypass surgery. Participants will be asked to take part in this study at three time points: 1) before their bariatri...
What is the current status of trial NCT01214382?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2010-10. Estimated completion is 2014-08.
What conditions does trial NCT01214382 study?
This clinical trial studies the following conditions: Roux en Y Gastric Bypass Surgery.
What interventions are being tested in trial NCT01214382?
The interventions under investigation include: Sertraline (DRUG).
Who is sponsoring clinical trial NCT01214382?
This trial is sponsored by North Dakota State University, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01214382 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01214382's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 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
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
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