Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Not Applicable

Completed

• Conditions: Healthy Adults
• Interventions: Other: Thermosensitive gel rectal formulation; Other: Saline enema

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline enema	Saline enema	Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Thermosensitive gel formulation	Saline enema	Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Thermosensitive gel formulation	Thermosensitive gel rectal formulation	Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Saline enema	Thermosensitive gel rectal formulation	Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.

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