NCT02290665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 30, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2015

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

November 6, 2014

Last Update Submit

August 14, 2018

Conditions

Healthy Adults

Keywords

enema

Outcome Measures

Primary Outcomes (1)

  • Patient preference, as assessed by questionnaire

    Up to 3 hours post-administration

Study Arms (2)

Thermosensitive gel formulation

EXPERIMENTAL

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

Other: Thermosensitive gel rectal formulationOther: Saline enema

Saline enema

EXPERIMENTAL

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

Other: Thermosensitive gel rectal formulationOther: Saline enema

Interventions

Thermosensitive gel rectal formulationOTHER
Saline enemaThermosensitive gel formulation
Saline enemaOTHER
Saline enemaThermosensitive gel formulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy
  • Age 18 to 70 years old
  • Non-pregnant

You may not qualify if:

  • GI complaints
  • Pregnancy
  • Patients with previous colonic surgery or current bowel injury or obstruction
  • Allergies to contrast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Study Officials

  • Sidhartha Sinha, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Aida Habtezion, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 14, 2014

Study Start

January 30, 2015

Primary Completion

September 28, 2015

Study Completion

September 28, 2015

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

US(1)