Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

August 14, 2018 updated by: Sidhartha R Sinha, Stanford University
The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94204
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntarily sign written informed consent.
  • Male or non-pregnant and non-lactating females at least 8 years of age.
  • Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease).

Exclusion Criteria:

  • Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
  • 5-aminosalicylic acid (5-ASA) intolerance
  • Current or recent (3 weeks) oral or rectal steroids
  • History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis
  • Abnormal creatinine
  • Previous small bowel or colonic resection,
  • Anal sphincter incompetence,
  • Current smokers.
  • History or current diagnosis of Crohn's disease or indeterminate colitis.
  • History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
  • Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
  • Hemoglobin levels < 7.5 g/dL.
  • History of sclerosing cholangitis, cirrhosis, or hepatic impairment
  • Pregnant or at risk of pregnancy.
  • Some medications to treat UC are prohibited during participation in the study, including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber supplements are allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermosensitive gel formulation
Thermosensitive gel rectal formulation.
Drug: Thermosensitive gel rectal formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)
Time Frame: Between 4-6 weeks post-administration
Using Modified Mayo Score
Between 4-6 weeks post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 16, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB- 34970

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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