A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis

Altheus Therapeutics, Inc.45 sites in 1 country120 target enrollmentJune 2012

ConditionsUlcerative Colitis Left-sided Ulcerative Colitis Distal Ulcerative Colitis

InterventionsMesalamine Enema

DrugsZoenasa-1:4 Mesalamine Enema

Overview

Phase: Phase 2
Intervention: Mesalamine Enema
Conditions: Ulcerative Colitis
Sponsor: Altheus Therapeutics, Inc.
Enrollment: 120
Locations: 45
Primary Endpoint: Change in modified UCDAI at 6 weeks
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

April 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Altheus Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years.
•They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild to moderate active disease.
•Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI score of 4-10, inclusive, with a Physician's rating of disease score of 2 points or less (mild or moderate active ulcerative colitis), rectal bleeding score of 1 or more (based on subject diary), and mucosal appearance score (based on endoscopy) of 1 point or more at baseline.
•Laboratory data:
•White blood cell count between 4.0 - 12.0 K/mm3
•Platelet count: 150 - 500 K/mm3
•Hemoglobin \> 10.0 g/dL
•Total bilirubin \< 1.5 mg/dL
•Aspartate aminotransferase \< 100 u/dL
•Alanine aminotransferase \< 100 u/dL

Exclusion Criteria

•They have documented history of proximal or universal ulcerative colitis, proctitis or active proctitis confined to 15cm or less from the anal verge.
•They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
•They receive a Physician's rating of disease severity as part of the modified UCDAI of 3 (severe disease) or an aggregate score of 11 or greater.
•They have shown prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
•Their stool contains enteric pathogens or Clostridium difficile toxins.
•They have a history of recurrent Clostridium difficile infection.
•They have prior history of biologic therapy within the previous 4 years.
•They have received systemic steroids or immunosuppressants within the previous 4 weeks.
•Treatment in the last 14 days that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) or mesalamine enema (Rowasa®).
•Treatment in the last 7 days that included mesalamine (5-ASA) via oral administration (e.g. Asacol®, Lialda®, balsalazide, etc).

Arms & Interventions

Mesalamine Enema

Intervention: Mesalamine Enema

Outcomes

Primary Outcomes

Change in modified UCDAI at 6 weeks

Time Frame: 6 weeks

Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 6 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine