Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
- Conditions
- Left-sided Ulcerative ColitisUlcerative ColitisDistal Ulcerative Colitis
- Interventions
- Registration Number
- NCT01586533
- Lead Sponsor
- Altheus Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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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.
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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.
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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
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Satisfies one of the following:
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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.
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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.
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They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesalamine Enema Mesalamine Enema -
- Primary Outcome Measures
Name Time Method Change in modified UCDAI at 6 weeks 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
- Secondary Outcome Measures
Name Time Method Time to resolution of rectal bleeding Up to 6 weeks Clinical and endoscopic remission rates at 6 weeks 6 weeks Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline
Endoscopic improvement rate at 3 weeks 3 weeks Clinical improvement rate after 6 weeks 6 weeks Clinical improvement rate after 3 weeks 3 weeks Endoscopic improvement rate at 6 weeks 6 weeks Change from baseline in endoscopic appearance after 6 weeks 6 weeks Change from baseline in endoscopic appearance after 3 weeks 3 weeks Relapse rates at 6 weeks 6 weeks Change in modified UCDAI at 3 weeks 3 weeks Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 3 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine
Clinical and endoscopic remission rates at 3 weeks 3 weeks Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline
Trial Locations
- Locations (45)
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
Scroll for more (35 remaining)Birmingham Gastroenterology Associates🇺🇸Birmingham, Alabama, United States