Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Phase 1

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Thermosensitive gel rectal formulation

• Registration Number: NCT02745678
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thermosensitive gel formulation	Thermosensitive gel rectal formulation	Thermosensitive gel rectal formulation.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States