Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

NCT ID: NCT02745678

Last Updated: 2018-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-11-30

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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thermosensitive gel formulation

Thermosensitive gel rectal formulation.

Group Type: EXPERIMENTAL

Thermosensitive gel rectal formulation

Intervention Type: DRUG

Interventions

Thermosensitive gel rectal formulation

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sidhartha R Sinha

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

IRB- 34970

Identifier Type: -

Identifier Source: org_study_id