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

Status unconfirmed · Phase 2

Conditions studied: Ulcerative Colitis, Left-sided Ulcerative Colitis, Distal Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01586533

Run by

Altheus Therapeutics, Inc.

People needed

120

Starts

2012-06-01

Last updated by the study team

2014-01-08

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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