Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Completed · Not applicable

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT02290665

Run by

Stanford University

People needed

18

Starts

2015-01-30

Expected to finish

2015-09-28

Last updated by the study team

2018-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Generally healthy
• Age 18 to 70 years old
• Non-pregnant

You may not qualify if…

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

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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