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Localized Therapeutics for the Treatment of Gastrointestinal Disorders

NCT02290665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-08-16

No results posted yet for this study

Summary

The purpose of this study is to determine the patient preference for a biocompatible thermosensitive solution-gel versus water or saline (liquid) enema. The thermosensitive solution-gel is comprised of poloxamer, an inactive compound that is designated as GRAS (generally recognized as safe) by FDA. It could subsequently be used as a medium for drug delivery. The poloxamer (gel) is administered to study participants in order to assess preference and proximal distribution.

Conditions

  • Healthy Adults

Interventions

OTHER

Thermosensitive gel rectal formulation

OTHER

Saline enema

Sponsors & Collaborators

Principal Investigators

  • Sidhartha Sinha, MD · Stanford University

  • Aida Habtezion, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-30
Primary Completion
2015-09-28
Completion
2015-09-28

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02290665 on ClinicalTrials.gov