Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

NCT02745678 | Completed Phase 1

• 1 other identifier: IRB- 34970
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ulcerative

Keywords

Enema; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

  Between 4-6 weeks post-administration

Study Arms (1)

Thermosensitive gel formulation

EXPERIMENTAL

Thermosensitive gel rectal formulation.

Drug: Thermosensitive gel rectal formulation

Interventions

Thermosensitive gel rectal formulation DRUG

Thermosensitive gel formulation

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94204, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 20, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)