Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02745678

Enrollment

Registered

2016-04-20

Start date

2016-01-31

Completion date

2017-11-30

Last updated

2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

Keywords

Enema, Ulcerative Colitis

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.

Interventions

DRUGThermosensitive gel rectal formulation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and efficacy of a new formulation in patients with mild-to-moderately-active Ulcerative Colitis using the Mayo Disease Activity Index (MMDAI)	Between 4-6 weeks post-administration	Using Modified Mayo Score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026