Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
This study is currently recruiting participants.
Verified November 2013 by Altheus Therapeutics, Inc.
Information provided by (Responsible Party):
Altheus Therapeutics, Inc.
First received: April 25, 2012
Last updated: November 11, 2013
Last verified: November 2013
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.
Left-sided Ulcerative Colitis
Distal Ulcerative Colitis
Drug: Mesalamine Enema
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
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)
|Ages Eligible for Study:
||18 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586533
Altheus Therapeutics, Inc.
No publications provided
||Altheus Therapeutics, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 25, 2012
||November 11, 2013
||United States: Food and Drug Administration
Keywords provided by Altheus Therapeutics, Inc.:
left-sided ulcerative colitis
distal ulcerative colitis
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 12, 2013
Digestive System Diseases
Inflammatory Bowel Diseases
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents