Overview

This trial is active, not recruiting.

Conditions ulcerative colitis, left-sided ulcerative colitis, distal ulcerative colitis
Treatments zoenasa-1:4, mesalamine enema
Phase phase 2
Sponsor Altheus Therapeutics, Inc.
Start date June 2012
End date April 2014
Trial size 120 participants
Trial identifier NCT01586533, ZA-201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
zoenasa-1:4
Zoenasa Rectal Gel (4.0g mesalamine [5-ASA], 1.0g N-acetylcysteine [NAC]; 60ml)
(Active Comparator)
mesalamine enema
Mesalamine Rectal Suspension Enema (4.0g mesalamine [5-ASA], 60ml)

Primary Outcomes

Measure
Change in modified UCDAI at 6 weeks
time frame: 6 weeks

Secondary Outcomes

Measure
Change in modified UCDAI at 3 weeks
time frame: 3 weeks
Clinical and endoscopic remission rates at 6 weeks
time frame: 6 weeks
Clinical and endoscopic remission rates at 3 weeks
time frame: 3 weeks
Clinical improvement rate after 6 weeks
time frame: 6 weeks
Clinical improvement rate after 3 weeks
time frame: 3 weeks
Endoscopic improvement rate at 6 weeks
time frame: 6 weeks
Endoscopic improvement rate at 3 weeks
time frame: 3 weeks
Change from baseline in endoscopic appearance after 6 weeks
time frame: 6 weeks
Change from baseline in endoscopic appearance after 3 weeks
time frame: 3 weeks
Time to resolution of rectal bleeding
time frame: Up to 6 weeks
Relapse rates at 6 weeks
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Altheus Therapeutics, Inc..