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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Altheus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01586533
First received: April 25, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Left-sided Ulcerative Colitis
Distal Ulcerative Colitis
Drug: Zoenasa-1:4
Drug: Mesalamine Enema
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Altheus Therapeutics, Inc.:

Primary Outcome Measures:
  • Change in modified UCDAI at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in modified UCDAI at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline

  • Clinical and endoscopic remission rates at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline

  • Clinical improvement rate after 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Clinical improvement rate after 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Endoscopic improvement rate at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Endoscopic improvement rate at 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in endoscopic appearance after 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in endoscopic appearance after 3 weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Time to resolution of rectal bleeding [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Relapse rates at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zoenasa-1:4 Drug: Zoenasa-1:4
Zoenasa Rectal Gel (4.0g mesalamine [5-ASA], 1.0g N-acetylcysteine [NAC]; 60ml)
Active Comparator: Mesalamine Enema Drug: Mesalamine Enema
Mesalamine Rectal Suspension Enema (4.0g mesalamine [5-ASA], 60ml)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586533

  Hide Study Locations
Locations
United States, Alabama
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States, 35209
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
United States, Colorado
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States, 80214
United States, Florida
Digestive Disease Associates
Gainesville, Florida, United States, 32605
Digestive Medical Associates
Hialeah, Florida, United States, 33016
The Center for Gastrointestinal Disorders
Hollywood, Florida, United States, 33021
Miami Gastroenterology Consultants P.A.
Miami, Florida, United States, 33156
South Medical Research Group
Miami, Florida, United States, 33186
Gastroenterology of Naples
Naples, Florida, United States, 34102
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States, 34684
Shafran Gastroenterology
Winter Park, Florida, United States, 32789
United States, Georgia
Tri-County Research
Athens, Georgia, United States, 30606
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
The Atlanta Center for Gastroenterology
Decatur, Georgia, United States, 30033
St. Josephs Candler Health System
Savannah, Georgia, United States, 31405
United States, Illinois
NCH Medical Group
Arlington Heights, Illinois, United States, 60004
United States, Iowa
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, United States, 52807
United States, Kansas
Professional Research Network of Kansas
Wichita, Kansas, United States, 67203
United States, Louisiana
Clinical Trials Management of Louisiana
Metairie, Louisiana, United States, 70006
United States, Michigan
Dr. Jason Bozdin, M.D.
Berkley, Michigan, United States, 48072
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Gregory Cammel, MD PLC
Wyoming, Michigan, United States, 48418
United States, Mississippi
GI Associates and Endoscopy Center
Jackson, Mississippi, United States, 39202
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Research Associates of New York
New York, New York, United States, 10028
United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States, 28801
Carolina Digestive Health Associates
Davidson, North Carolina, United States, 28036
LeBauer Research Associates, P.A.
Greensboro, North Carolina, United States, 27403
United States, Ohio
Greater Cincinnati Gastroenterology
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73071
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Options Health Research
Tulsa, Oklahoma, United States, 74104
Gastroenterology United Tulsa
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
Gastro One
Germantown, Tennessee, United States, 38138
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Houston Digestive Disease Clinic
Houston, Texas, United States, 77090
Digestive Health Associates of Texas
Plano, Texas, United States, 75075
United States, Utah
Advanced Research Institute
South Ogden, Utah, United States, 84405
United States, Virginia
New River Valley Research Institute
Christiansburg, Virginia, United States, 24073
Digestive & Liver Disease Specialists
Norfolk, Virginia, United States, 23502
United States, Washington
Digestive Disease Institute
Seattle, Washington, United States, 98101
Franciscan Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Altheus Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Altheus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01586533     History of Changes
Other Study ID Numbers: ZA-201
Study First Received: April 25, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Altheus Therapeutics, Inc.:
ulcerative colitis
UC
left-sided ulcerative colitis
distal ulcerative colitis
Zoenasa
mesalamine
mesalazine
5-ASA
5-aminosalicylic acid
N-acetylcysteine
acetylcysteine
NAC
enema
rectal gel

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Acetylcysteine
N-monoacetylcystine
Mesalamine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014