Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Coal Tar

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.