Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
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
1 other identifier
interventional
120
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
April 27, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedJanuary 8, 2014
January 1, 2014
1.8 years
April 25, 2012
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in modified UCDAI at 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
6 weeks
Secondary Outcomes (11)
Change in modified UCDAI at 3 weeks
3 weeks
Clinical and endoscopic remission rates at 6 weeks
6 weeks
Clinical and endoscopic remission rates at 3 weeks
3 weeks
Clinical improvement rate after 6 weeks
6 weeks
Clinical improvement rate after 3 weeks
3 weeks
- +6 more secondary outcomes
Study Arms (2)
Zoenasa-1:4
EXPERIMENTALMesalamine Enema
ACTIVE COMPARATORInterventions
Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)
Mesalamine Rectal Suspension Enema (4.0g mesalamine \[5-ASA\], 60ml)
Eligibility Criteria
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.
- +2 more criteria
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).
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80214, United States
Digestive Disease Associates
Gainesville, Florida, 32605, United States
Digestive Medical Associates
Hialeah, Florida, 33016, United States
The Center for Gastrointestinal Disorders
Hollywood, Florida, 33021, United States
Miami Gastroenterology Consultants P.A.
Miami, Florida, 33156, United States
South Medical Research Group
Miami, Florida, 33186, United States
Gastroenterology of Naples
Naples, Florida, 34102, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, 34684, United States
Shafran Gastroenterology
Winter Park, Florida, 32789, United States
Tri-County Research
Athens, Georgia, 30606, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
The Atlanta Center for Gastroenterology
Decatur, Georgia, 30033, United States
St. Josephs Candler Health System
Savannah, Georgia, 31405, United States
NCH Medical Group
Arlington Heights, Illinois, 60004, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, 52807, United States
Professional Research Network of Kansas
Wichita, Kansas, 67203, United States
Clinical Trials Management of Louisiana
Metairie, Louisiana, 70006, United States
Dr. Jason Bozdin, M.D.
Berkley, Michigan, 48072, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Gregory Cammel, MD PLC
Wyoming, Michigan, 48418, United States
GI Associates and Endoscopy Center
Jackson, Mississippi, 39202, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Research Associates of New York
New York, New York, 10028, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
Carolina Digestive Health Associates
Davidson, North Carolina, 28036, United States
LeBauer Research Associates, P.A.
Greensboro, North Carolina, 27403, United States
Greater Cincinnati Gastroenterology
Cincinnati, Ohio, 45219, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Gastroenterology United Tulsa
Tulsa, Oklahoma, 74135, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Gastro One
Germantown, Tennessee, 38138, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Houston Digestive Disease Clinic
Houston, Texas, 77090, United States
Digestive Health Associates of Texas
Plano, Texas, 75075, United States
Advanced Research Institute
South Ogden, Utah, 84405, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Digestive Disease Institute
Seattle, Washington, 98101, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2012
First Posted
April 27, 2012
Study Start
June 1, 2012
Primary Completion
April 1, 2014
Last Updated
January 8, 2014
Record last verified: 2014-01