Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01257477 · ClinicalTrials.gov registry record
LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
A clinical trial of Irritable Bowel Syndrome, sponsored by Prometheus Laboratories.
- Completed
- Registry status
- 400
- Enrollment target
- 20
- Study locations
NCT01257477: Completed study of Irritable Bowel Syndrome, sponsored by Prometheus Laboratories.
NCT01257477 is a study of Irritable Bowel Syndrome that has completed, run by Prometheus Laboratories. The registered enrollment target is 400 participants, above the 136-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (194% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01257477, a study of Irritable Bowel Syndrome, has completed, sponsored by Prometheus Laboratories.
- COMPLETED
- Registry status
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.
Primary Outcome
Stool consistency as measured by the Bristol Stool Form Scale. Change from baseline at Weeks 4 and 12 will be determined.
Conditions Studied
Study Locations (20)
California
- Adam D. Karns, MD - Beverly Hills
- Behavioral Research Specialists, LLC - Irvine
- Torrance Clinical Research - Lomita
- Community Clinical Trials - Orange
- Inland Gastroenterology Medical Associates - Redlands
- Digestive Care Associates - San Carlos
- Clinical Applications Laboratories, Inc. - San Diego
- Precision Research Institute, LLC - San Diego
Florida
- Consultants for Clinical Research of South Florida - Boynton Beach
- Sanitas Research - Coral Gables
- Avail Clinical Research, LLC - DeLand
- Southern Clinical Research Consultants - Hollywood
- Borland-Groover Clinic - Jacksonville
- Advanced Gastroenterology Associates, LLC - Palm Harbor
Colorado
- Delta Waves Sleep Disorders & Research Center - Colorado Springs
- Clinical Research of the Rockies - Lafayette
Alabama
- Gastroenterology Consultants Inc. - Tuscaloosa
Arizona
- Digestive Health Research Unit - Scottsdale
Arkansas
- Lynn Institute of the Ozarks - Little Rock
Connecticut
- Gastroenterology Associates of Fairfield County - Bridgeport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-03 |
What the finished NCT01257477 record still lists
NCT01257477 is an observational study that tracks outcomes without assigning an intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (194% higher).
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT01257477 names 20 study sites across 7 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01257477 about?
NCT01257477 is a clinical study titled "LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)". An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.
What is the current status of trial NCT01257477?
This trial is currently completed. The enrollment target is 400 participants. The study started on 2010-11. Estimated completion is 2013-03.
What conditions does trial NCT01257477 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome.
Who is sponsoring clinical trial NCT01257477?
This trial is sponsored by Prometheus Laboratories, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01257477 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Irritable Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01257477's enrollment target sits among peer trials
400 3rd of 47 higher than 45 of 47 other Irritable Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Irritable Bowel Syndrome 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
-
Do Biomarkers Predict Response to a Pediatric Chronic Pain Symptom Management Program?
RECRUITING · NA
-
Drug Interaction Potential of Pro-Inflammatory Conditions
RECRUITING
-
Psyllium in Pediatric IBS
RECRUITING · Phase 2
-
Mucosal and Microbiota Changes During Acute Campylobacteriosis
RECRUITING
-
GI Alpha-Gal Study
RECRUITING · NA
-
Visible Abdominal Distension
RECRUITING · NA
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
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
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