Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Not Applicable

Completed

• Conditions: Healthy Adults

• Registration Number: NCT02290665
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Study Start: 2015-01-30
• Primary Completion: 2015-09-28
• Study Completion: 2015-09-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Patient preference, as assessed by questionnaire	Up to 3 hours post-administration

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States