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