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
?
mi
from
Birmingham, AL
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
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
Jackson, Mississippi 39202
?
mi
from
Jackson, MS
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