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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01586533
• Date of registration: 25/04/2012
• Prospective Registration: Yes
• Primary sponsor: Altheus Therapeutics, Inc.
• Public title: Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis
• Scientific 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
• Date of first enrolment: June 2012
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01586533
• 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
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Left-sided Ulcerative Colitis

Ulcerative Colitis

Distal Ulcerative Colitis

Intervention(s)

Drug: Mesalamine Enema

Drug: Zoenasa-1:4

Primary Outcome(s)

Change in modified UCDAI at 6 weeks [Time Frame: 6 weeks]

Secondary Outcome(s)

Endoscopic improvement rate at 3 weeks [Time Frame: 3 weeks]

Clinical improvement rate after 3 weeks [Time Frame: 3 weeks]

Clinical improvement rate after 6 weeks [Time Frame: 6 weeks]

Change from baseline in endoscopic appearance after 3 weeks [Time Frame: 3 weeks]

Change from baseline in endoscopic appearance after 6 weeks [Time Frame: 6 weeks]

Relapse rates at 6 weeks [Time Frame: 6 weeks]

Clinical and endoscopic remission rates at 3 weeks [Time Frame: 3 weeks]

Clinical and endoscopic remission rates at 6 weeks [Time Frame: 6 weeks]

Change in modified UCDAI at 3 weeks [Time Frame: 3 weeks]

Endoscopic improvement rate at 6 weeks [Time Frame: 6 weeks]

Time to resolution of rectal bleeding [Time Frame: Up to 6 weeks]

Secondary ID(s)

ZA-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors