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Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel Syndrome

NCT04046328 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-07-19

Study results available
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Summary

A new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults. The formulation is expected to release cholestyramine in the remaining segment of the small intestine in SBS patients, thus binding bile acids after fat digestion, but before induction of diarrhea in the colon. The delayed-release profile is also expected to help reduce the potential for drug-drug interactions occurring in the proximal small intestine. Two doses of ECC will be studied for efficacy, safety and tolerability in this Phase IIa trial.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Enteric-Coated Cholestyramine (ECC) Capsule

Enteric-Coated Delayed Release Cholestyramine Capsules

DRUG

Placebo

Enteric-Coated Delayed Release Placebo Capsules

Sponsors & Collaborators

  • Pharmascience Inc.

    lead INDUSTRY

Principal Investigators

  • Marek Kunecki, MD, PhD · Wojewódzki Specjalistyczny Szpital im. M. Pirogowa w Łodzi

  • Konrad Matysiak, MD, PhD · Solumed Centrum Medyczne

  • Kinga Szczepanek, MD · Szpital Wielospecjalistyczny im. Stanleya Dudricka

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2021-12-22
Completion
2021-12-22
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046328 on ClinicalTrials.gov