Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Healthy Adults Clinical Trial

Official title:

Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290665
• Other study ID #: IRB-29620
• Status: Completed
• Phase: N/A
• Start date: January 30, 2015
• Est. completion date: September 28, 2015

Study information

• Verified date: August 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 28, 2015
• Est. primary completion date: September 28, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Healthy Adults

Intervention

Other:
• Thermosensitive gel rectal formulation

• Saline enema

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient preference, as assessed by questionnaire		Up to 3 hours post-administration