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Localized Therapeutics for the Treatment of Gastrointestinal Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290665
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sidhartha R Sinha, 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.

Condition or disease Intervention/treatment Phase
Healthy Adults Other: Thermosensitive gel rectal formulation Other: Saline enema Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Localized Therapeutics for the Treatment of Gastrointestinal Disorders
Actual Study Start Date : January 30, 2015
Actual Primary Completion Date : September 28, 2015
Actual Study Completion Date : September 28, 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Patient preference, as assessed by questionnaire [ Time Frame: Up to 3 hours post-administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290665


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sidhartha Sinha, MD Stanford University
Principal Investigator: Aida Habtezion, MD Stanford University
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Responsible Party: Sidhartha R Sinha, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02290665    
Other Study ID Numbers: IRB-29620
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Keywords provided by Sidhartha R Sinha, Stanford University:
enema
Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases