Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01396213 · ClinicalTrials.gov registry record · Phase 2
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
A Phase 2 study, sponsored by 9 Meters Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 342
- Enrollment target
NCT01396213: Completed Phase 2 study, sponsored by 9 Meters Biopharma.
NCT01396213 is a Phase 2 study that has completed, run by 9 Meters Biopharma. The registered enrollment target is 342 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01396213, a Phase 2 study, has completed, sponsored by 9 Meters Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 342 participants
- Enrollment target
Study Summary
A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
Primary Outcome
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
Interventions
- DRUG placebo
- DRUG Larazotide Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 342 participants |
| Start Date | 2011-11-07 |
| Est. Completion | 2013-08-20 |
| Phase | Phase 2 |
What the finished NCT01396213 record still lists
NCT01396213 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (157% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01396213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01396213 about?
NCT01396213 is a clinical study titled "A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease". A randomized, double-blind, placebo-controlled Phase 2B study to evaluate the efficacy and safety of Larazotide Acetate in the treatment of patients with celiac disease who have persistent symptoms despite being on a gluten-free diet.
What is the current status of trial NCT01396213?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 342 participants. The study started on 2011-11-07. Estimated completion is 2013-08-20.
What interventions are being tested in trial NCT01396213?
The interventions under investigation include: placebo (DRUG), Larazotide Acetate (DRUG).
Who is sponsoring clinical trial NCT01396213?
This trial is sponsored by 9 Meters Biopharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01396213's enrollment target sits among peer trials
342 136th of 2000 higher than 1,864 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT05283850 · 342 participants · Phase 2
Surviving PEA in Roanoke (SPEAR) Study
- NCT05714085 · 342 participants · Phase 2
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
- NCT06188702 · 342 participants · Phase 1
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
- NCT06544941 · 342 participants · NA
Improving Maternal Sleep and Mental Health
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI