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NCT02475369 · ClinicalTrials.gov registry record · Phase 4

Pancreatic Enzyme Supplementation for Celiac Disease

A Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.

Terminated
Registry status
Phase 4
Development phase
21
Enrollment target

NCT02475369: Clinical Trial Phase 4 study, sponsored by Beth Israel Deaconess Medical Center.

NCT02475369 is a Phase 4 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02475369, a Phase 4 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.

TERMINATED
Registry status
Phase 4
Development phase
21 participants
Enrollment target

Study Summary

The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to: 1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet. 2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.

Primary Outcome

The average per individual subject on-treatment score in the Celiac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS) domains of Diarrhea, Indigestion, and Abdominal pain comparing active treatment to placebo (i.e. a paired comparison of CeD GSRS on treatment versus on placebo for each subject). CeD-GSRS: Each individual sub-section of the 15 sub-sections scores from 1 to 7, with greater scores indicating worse symptoms. A total score can range from 15 -105. This is then divided by 15 to

Interventions

  • DRUG pancrelipase

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2015-05
Est. Completion 2019-12
Phase Phase 4

Why NCT02475369 stopped before completion

NCT02475369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which pancrelipase is the first listed.

NCT02475369 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02475369 about?

NCT02475369 is a clinical study titled "Pancreatic Enzyme Supplementation for Celiac Disease". The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to: 1. Evaluate the efficacy of pancr...

What is the current status of trial NCT02475369?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2015-05. Estimated completion is 2019-12.

What interventions are being tested in trial NCT02475369?

The interventions under investigation include: pancrelipase (DRUG).

Who is sponsoring clinical trial NCT02475369?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02475369's enrollment target sits among peer trials

21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT02475369, the US trial registry maintained by the National Library of Medicine. NCT02475369 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.