Localized Therapeutics for the Treatment of Gastrointestinal Disorders

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.

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Key information

Conditions

Healthy Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Generally healthy
Age 18 to 70 years old
Non-pregnant

Exclusion criteria

GI complaints
Pregnancy
Patients with previous colonic surgery or current bowel injury or obstruction
Allergies to contrast

Treatment and study plan

Thermosensitive gel rectal formulation

Other

Saline enema

Other

Primary outcomes

Patient preference, as assessed by questionnaire

Time frame: Up to 3 hours post-administration

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Nov 14, 2014
Registry last updated: Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed