Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Stanford University

Status and phase

Completed

Phase 1

Conditions

Colitis, Ulcerative

Treatments

Drug: Thermosensitive gel rectal formulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02745678

IRB- 34970

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

8+ years old

Volunteers

No 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.