Back to results

Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Primary Purpose

Colitis, Ulcerative

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Thermosensitive gel rectal formulation

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Enema, Ulcerative Colitis

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thermosensitive gel formulation

Arm Description

Thermosensitive gel rectal formulation.

Outcomes

Primary Outcome Measures

Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)

Using Modified Mayo Score

Secondary Outcome Measures

Full Information

NCT ID

NCT02745678

First Posted

March 23, 2016

Last Updated

August 14, 2018

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT02745678

Brief Title

Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Official Title

Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colitis, Ulcerative

Keywords

Enema, Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thermosensitive gel formulation

Arm Type

Experimental

Arm Description

Thermosensitive gel rectal formulation.

Intervention Type

Drug

Intervention Name(s)

Thermosensitive gel rectal formulation

Primary Outcome Measure Information:

Title

Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)

Description

Using Modified Mayo Score

Time Frame

Between 4-6 weeks post-administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94204

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

We'll reach out to this number within 24 hrs