Localized Therapeutics for the Treatment of Gastrointestinal Disorders

August 14, 2018 updated by: Sidhartha R Sinha, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermosensitive gel formulation
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Other: Saline enema
Other: Thermosensitive gel rectal formulation
Experimental: Saline enema
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Other: Saline enema
Other: Thermosensitive gel rectal formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient preference, as assessed by questionnaire
Time Frame: Up to 3 hours post-administration
Up to 3 hours post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Aida Habtezion, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2015

Primary Completion (Actual)

September 28, 2015

Study Completion (Actual)

September 28, 2015

Study Registration Dates

First Submitted

November 6, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-29620

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Adults

Clinical Trials on Saline enema

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe