Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Colitis, Ulcerative Clinical Trial

Official title:

Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745678
• Other study ID #: IRB- 34970
• Status: Completed
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: November 2017

Study information

• Verified date: August 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Digestive System Diseases
• Gastrointestinal Diseases
• Ulcer

Intervention

Drug:
• Thermosensitive gel rectal formulation

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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