Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

NCT ID: NCT01586533

Last Updated: 2014-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30

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.

Conditions

Ulcerative Colitis; Left-sided Ulcerative Colitis; Distal Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zoenasa-1:4

Group Type: EXPERIMENTAL

Zoenasa-1:4

Intervention Type: DRUG

Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)

Mesalamine Enema

Group Type: ACTIVE_COMPARATOR

Mesalamine Enema

Intervention Type: DRUG

Mesalamine Rectal Suspension Enema (4.0g mesalamine \[5-ASA\], 60ml)

Interventions

Zoenasa-1:4

Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)

Intervention Type: DRUG

Mesalamine Enema

Mesalamine Rectal Suspension Enema (4.0g mesalamine \[5-ASA\], 60ml)

Intervention Type: DRUG

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
• Alkaline phosphatase < 250 u/dL
• Blood urine nitrogen < 40 mg/dL
• Creatinine < 1.5 mg/dL
• Satisfies one of the following:
• Female subjects of childbearing potential must have a negative urine pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.
• Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.
• They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

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).
• They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
• Positive pregnancy test or lactating subjects.
• There is evidence of chemical substance abuse.
• They have had repeated anti-inflammatory drug treatment (longer than 3 days at doses that exceed those available without a prescription) within the previous 7 days (with exception of aspirin at doses of 325mg/day or less for prophylaxis of cardiac disease), or initiated new non-steroidal anti-inflammatory (NSAID) treatment within the last 30 days.
• They have a known allergy to N-acetylcysteine or mesalamine, or have a history of serious AEs related to their use (including, but not limited to pancreatitis or hepatitis).
• They have a history of failure to retain enemas.
• Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
• Use of any investigational medication within the previous 90 days.
• Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Altheus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham Gastroenterology Associates

Birmingham, Alabama, United States

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Rocky Mountain Gastroenterology

Lakewood, Colorado, United States

Digestive Disease Associates

Gainesville, Florida, United States

Digestive Medical Associates

Hialeah, Florida, United States

The Center for Gastrointestinal Disorders

Hollywood, Florida, United States

Miami Gastroenterology Consultants P.A.

Miami, Florida, United States

South Medical Research Group

Miami, Florida, United States

Gastroenterology of Naples

Naples, Florida, United States

Advanced Gastroenterology Associates

Palm Harbor, Florida, United States

Shafran Gastroenterology

Winter Park, Florida, United States

Tri-County Research

Athens, Georgia, United States

Digestive Healthcare of Georgia

Atlanta, Georgia, United States

The Atlanta Center for Gastroenterology

Decatur, Georgia, United States

St. Josephs Candler Health System

Savannah, Georgia, United States

NCH Medical Group

Arlington Heights, Illinois, United States

Gastrointestinal Clinic of Quad Cities

Davenport, Iowa, United States

Professional Research Network of Kansas

Wichita, Kansas, United States

Clinical Trials Management of Louisiana

Metairie, Louisiana, United States

Dr. Jason Bozdin, M.D.

Berkley, Michigan, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Gregory Cammel, MD PLC

Wyoming, Michigan, United States

GI Associates and Endoscopy Center

Jackson, Mississippi, United States

Long Island Clinical Research Associates

Great Neck, New York, United States

Research Associates of New York

New York, New York, United States

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, United States

Carolina Digestive Health Associates

Davidson, North Carolina, United States

LeBauer Research Associates, P.A.

Greensboro, North Carolina, United States

Greater Cincinnati Gastroenterology

Cincinnati, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Options Health Research

Tulsa, Oklahoma, United States

Gastroenterology United Tulsa

Tulsa, Oklahoma, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Gastro One

Germantown, Tennessee, United States

Memphis Gastroenterology Group

Germantown, Tennessee, United States

Dallas VA Medical Center

Dallas, Texas, United States

Houston Digestive Disease Clinic

Houston, Texas, United States

Digestive Health Associates of Texas

Plano, Texas, United States

Advanced Research Institute

South Ogden, Utah, United States

New River Valley Research Institute

Christiansburg, Virginia, United States

Digestive & Liver Disease Specialists

Norfolk, Virginia, United States

Digestive Disease Institute

Seattle, Washington, United States

Franciscan Research Center

Tacoma, Washington, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

ZA-201

Identifier Type: -

Identifier Source: org_study_id