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



Status:Recruiting
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 64
Updated:1/1/2014
Start Date:June 2012
Contact:Harry Cook, RPh, MBA
Email:hcook@altheustherapeutics.com
Phone:405-319-8184

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
45
sites
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
Click here to add this to my saved trials
4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Arlington Heights, Illinois 60004
?
mi
from
Arlington Heights, IL
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Athens, Georgia 30606
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Berkley, Michigan 48072
?
mi
from
Berkley, MI
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Chesterfield, Michigan 48098
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Christiansburg, Virginia 24073
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Davenport, IA
Click here to add this to my saved trials
Davidson, North Carolina 28036
?
mi
from
Davidson, NC
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Gainesville, Florida 32605
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greensboro, North Carolina 27406
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Hialeah, Florida 33016
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77090
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lakewood, Colorado 80214
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Metairie, Louisiana 70006
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33186
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
New York, New York 10028
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Norman, Oklahoma 73069
?
mi
from
Norman, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Savannah, Georgia 31405
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
South Ogden, Utah 84405
?
mi
from
South Ogden, UT
Click here to add this to my saved trials
Tacoma, Washington 98405
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tulsa, Oklahoma 74137
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Tulsa, Oklahoma 74135
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
Wyoming, Michigan 48418
?
mi
from
Wyoming, MI
Click here to add this to my saved trials