Trial record 1 of 457 for:
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.
Information provided by (Responsible Party):
Altheus Therapeutics, Inc.
First received: April 25, 2012
Last updated: January 7, 2014
Last verified: January 2014
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:
||April 2014 (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.
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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
||January 7, 2014
||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 September 18, 2014
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