Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
Completed · Phase 1
Conditions studied: Colitis, Ulcerative
In brief
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.
Key facts
- Study ID
- NCT02745678
- Run by
- Stanford University
- People needed
- 3
- Starts
- 2016-01-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-08-16
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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.
Where it is running
- Stanford University — Stanford, California, United States
Full record on ClinicalTrials.gov
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