Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Trial ID or NCT#

NCT02290665

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - Generally healthy - Age 18 to 70 years old - Non-pregnant
Exclusion Criteria:
  1. - GI complaints - Pregnancy - Patients with previous colonic surgery or current bowel injury or obstruction - Allergies to contrast
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Contact

Sidhartha Sinha, MD

View on ClinicalTrials.gov