search
Back to results

Localized Therapeutics for the Treatment of Gastrointestinal Disorders

Primary Purpose

Healthy Adults

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thermosensitive gel rectal formulation
Saline enema
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Adults focused on measuring enema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thermosensitive gel formulation

Saline enema

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient preference, as assessed by questionnaire

Secondary Outcome Measures

Full Information

First Posted
November 6, 2014
Last Updated
August 14, 2018
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT02290665
Brief Title
Localized Therapeutics for the Treatment of Gastrointestinal Disorders
Official Title
Localized Therapeutics for the Treatment of Gastrointestinal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2015 (Actual)
Primary Completion Date
September 28, 2015 (Actual)
Study Completion Date
September 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Adults
Keywords
enema

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermosensitive gel formulation
Arm Type
Experimental
Arm Description
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Arm Title
Saline enema
Arm Type
Experimental
Arm Description
Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.
Intervention Type
Other
Intervention Name(s)
Thermosensitive gel rectal formulation
Intervention Type
Other
Intervention Name(s)
Saline enema
Primary Outcome Measure Information:
Title
Patient preference, as assessed by questionnaire
Time Frame
Up to 3 hours post-administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidhartha Sinha, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aida Habtezion, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Localized Therapeutics for the Treatment of Gastrointestinal Disorders

We'll reach out to this number within 24 hrs