Localized Therapeutics for the Treatment of Gastrointesti... | NCT02290665

Studies
Localized Therapeutics for the Treatment of Gastrointestinal Disorders

NCT02290665

Sponsor

Stanford University

Status

Completed

Last Update Posted

Aug 16, 2018Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Healthy Adults

Interventions

Thermosensitive gel rectal formulation
Saline enema

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2015Actual

Primary Completion Date

Sep 28, 2015Actual

Completion Date

Sep 28, 2015Actual

First Submitted Date

Nov 6, 2014

First Submission Date that Met QC Criteria

Nov 10, 2014

First Posted Date

Nov 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2018

Last Update Posted Date

Aug 16, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermosensitive gel formulation	Experimental	Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.	Other: Thermosensitive gel rectal formulation Other: Saline enema
Saline enema	Experimental	Thermosensitive gel rectal formulation or saline (control) enema with crossover to the other.	Other: Thermosensitive gel rectal formulation Other: Saline enema

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermosensitive gel rectal formulation	Other		Saline enema Thermosensitive gel formulation
Saline enema

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sidhartha Sinha, MD	Stanford University	Principal Investigator
Aida Habtezion, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305	United States