Phase
Condition
Ulcerative Colitis
Crohn's Disease
Inflammatory Bowel Disease
Treatment
N/AClinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the followingcriteria apply:
An Institutional Review Board (IRB) approved informed consent is signed and datedprior to any study-related activities.
Subject is a male or, if the subject is female, she is eligible to enter if she is of: Non-childbearing potential (i.e. physiologically incapable of becoming pregnant,including any female who has undergone sterilization [hysterectomy or bilateral tuballigation] or is post-menopausal. For purposes of this study, postmenopausal is definedas 1 year without menses); OR, Childbearing potential, has a negative serum pregnancy test at screen and, ifheterosexually active, agrees to one of the following:
Double barrier method of contraception, specifically, use of a condom andspermicide, for 1 week prior to study drug administration, throughout the 8 weekTreatment Phase.
Oral contraceptives administered for at least 2 monthly cycles prior to studydrug administration during all 6 months of study drug administration andadministered for 1 monthly cycle following completion of the study.
An intrauterine device (IUD), inserted by a qualified clinician, with publisheddata showing that the lowest expected failure rate is less than or equal to 1%per year (not all IUDs meet this criterion).
Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1monthly cycle prior to the study drug administration, during all 6 months ofstudy drug administration, and administered for 1 monthly cycle following studycompletion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evrapatch) administered for at least 2 monthly cycles prior to study drugadministration and administered for 2 monthly cycles following study completion
Partner has undergone vasectomy and subject is in a monogamous relationship. Theinvestigator is responsible for determining whether the subject is usingappropriate birth control for study participation.
Subject is greater than or equal to 18 years of age.
Subjects with mildly to moderately active ulcerative colitis experiencingsymptoms of an acute flare within the past 4 weeks.
Subject has not taken more than 2.4 grams of mesalamine or equivalent for a continuousperiod of 4 weeks preceding the screening visit
Subjects must have a baseline Modified Mayo Disease Activity Index (MMDAI) scorebetween 6 and 10, inclusive. Additionally, subjects must score greater than or equalto 2 on Bleeding and greater than or equal to 2 on Endoscopy/Sigmoidoscopy.
Subject is capable and willing to comply with all study procedures.
Disease extends at least 20 cm from the rectum on screening sigmoidoscopy.
Exclusion
Exclusion Criteria: A subject will not be eligible for inclusion in this study if any of the following criteriaapply (Note: Development of any of the following exclusion criteria on-study will beconsidered a basis for subject discontinuation.):
Subject has a significant medical, including psychiatric, condition which in theopinion of the investigator precludes participation in the study.
Subject has a history of allergy or intolerance to aspirin, mesalamine, or othersalicylates.
Subject has recently (within the past 30 days) failed therapy with balsalazidedisodium
Subject has received immunosuppressive therapy (e.g. azothioprine, 6 mercaptopurine)within 30 days, or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to screening.
Subject has received intra-rectal aminosalicylates within 14 days of screening.
Subject has had any prior bowel surgery, excepting appendectomy.
Subject has participated in an investigational drug or device study within the 30 daysprior to study screening, with the exception of Salix protocols 3003 & 3004 entitled: "A multicenter, randomized, double-blind, placebo controlled trial to evaluate the useof mesalamine pellet formulation 1.5G QD to maintain remission from mildly to moderateulcerative colitis."
Subject is pregnant or at risk of pregnancy, or is lactating (female subjects only).
Subject shows evidence of current excessive alcohol consumption or drug dependence.
Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C).
Subject has other infectious, ischemic, or immunologic diseases with GI involvement.
Subject has twice the upper limit of normal (ULN) for any of the following LFTs:alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), alkalinephosphatase, or total bilirubin (except isolated elevation of unconjugated bilirubin).
Subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULNof serum creatinine or blood urea nitrogen (BUN) levels.
Subject has calculated creatinine clearance level of less than or equal to 60 mL/min.
Subject has unstable cardiovascular, coagulopathy or pulmonary disease.
Subject has active malignancy within the last 5 years, except basal cell carcinoma ofthe skin, or if female, in situ cervical carcinoma that has been surgically excised.
Subject has any condition or circumstance that would, in the opinion of theinvestigator, prevent completion of the study or interfere with analysis of studyresults, including history of noncompliance with treatments or visits.
Subject has sclerosing cholangitis.
Subject has positive stool culture for ovum and parasites (O and P) or C. difficile.
Subject has been treated with infliximab, cyclosporine, natalizumab, or methotrexatefor ulcerative colitis within the last 30 days prior to screening.
Regular use of NSAIDS except cardioprotective ASA (i.e., less than or equal to 162 mgASA per day).
Subject has received cell-depleting therapies such as the Adacolumn.
Subject requires antidiarrheal therapy during screening.
Subject has clinical or radiographic findings suggestive of serious UC complicationssuch as toxic megacolon or colonic perforation. Females of Reproductive Potential: If a female subject becomes pregnant while on this study, the study drug will bediscontinued immediately and the subject followed until the outcome of the pregnancy isknown. If a pregnancy occurs, it will be reported in the same manner as an unexpected AEusing the guidelines provided in Section 6.4.1.9. Premature Subject Discontinuation: A subject may be discontinued from the study for the following medical or administrativereasons:
Occurrence of an AE, which in the judgment of the investigator suggests anunacceptable risk to the subject (The investigator will follow the subject untilsatisfactory resolution of the AE or the AE is determined to be stable);
Development on-study of any condition which, in the opinion of the investigator or thestudy sponsor, places the subject at an unacceptable medical risk if he/she continues;
Pregnancy;
Subject request;
Institution of additional medical (rescue) therapy for UC. The investigator maydiscontinue individual subjects from the study at any time. Subjects will beencouraged to complete the study; however they may voluntarily withdraw at any time.The investigator must provide written documentation of the reason for discontinuationon the CRF. Regardless of the reason for withdrawal, all subjects will be asked toundergo an end of therapy evaluation. Every attempt will be made to obtain all the endof study assessments, including all of the subscales of the MMDAI (i.e., bowelfrequency, bleeding, physician's assessment, and endoscopy/sigmoidoscopy score). Subjects who withdraw or are withdrawn will not be replaced under this protocol.
Study Design
Study Description
Connect with a study center
Birmingham Gastroenterology Associates
Birmingham, Alabama 35209
United StatesSite Not Available
Spring Memorial Hospital
Mobile, Alabama 36608
United StatesSite Not Available
Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
United StatesSite Not Available
Advanced Clinical Research Institute
Anaheim, California 92801
United StatesSite Not Available
Lovelace Scientific Resources
Beverly Hills, California 90211
United StatesSite Not Available
Digestive Liver Disease Specialists, Medical Group
Garden Grove, California 92840
United StatesSite Not Available
Therapeutic Research Institute of Orange County
Laguna Hills, California 92653
United StatesSite Not Available
Long Beach VA Medical Center
Long Beach, California 90822
United StatesSite Not Available
Facey Medical Group
Mission Hills, California 91345
United StatesSite Not Available
Community Clinical Trials
Orange, California 92868
United StatesSite Not Available
Rider Research Group
San Francisco, California 94117
United StatesSite Not Available
John Jolley, M.D.
San Rafael, California 94901
United StatesSite Not Available
Lovelace Scientific Resources
Santa Ana, California 92704
United StatesSite Not Available
Santa Barbara Clinical Research
Santa Barbara, California 93108
United StatesSite Not Available
Connecticut Gastroenterology Institute
Bristol, Connecticut 06010
United StatesSite Not Available
Stamford Therapeutic Consortium
Stamford, Connecticut 06905
United StatesSite Not Available
Medical Research Unlimited
Hialeah, Florida 33013
United StatesSite Not Available
Mark Lamet, M.D.
Hollywood, Florida 33021
United StatesSite Not Available
Southern Clinical Research Consultants
Hollywood, Florida 33021
United StatesSite Not Available
United Medical Research
New Smyrna Beach, Florida 32168
United StatesSite Not Available
Venture Research Institute, LLC
North Miami Beach, Florida 33162
United StatesSite Not Available
Advanced Gastroenterology Associates
Palm Harbor, Florida 34684
United StatesSite Not Available
Advent Clinical Research
Sarasota, Florida 34239
United StatesSite Not Available
Lovelace Scientific Resources
Sarasota, Florida 34233
United StatesSite Not Available
Clinical Research of Tampa Bay, Inc.
Spring Hill, Florida 34609
United StatesSite Not Available
Metabolic Research Institute, Inc.
West Palm Beach, Florida 33401
United StatesSite Not Available
Gary Richter, M.D.
Atlanta, Georgia 30308
United StatesSite Not Available
The Atlanta Center for Gastroenterology
Decatur, Georgia 30033
United StatesSite Not Available
Gastroenterology Associates of Central Georgia
Macon, Georgia 31201
United StatesSite Not Available
Northwest Gastroenterologists S.C.
Arlington Heights, Illinois 60005
United StatesSite Not Available
University Digestive Health Center
Oak Forest, Illinois 60452
United StatesSite Not Available
Covenent Clinic
Waterloo, Iowa 50702
United StatesSite Not Available
Digestive Health Center
Topeka, Kansas 66606
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Digestive Health Center of Louisiana
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Sinai Medical Office Building
Baltimore, Maryland 21215
United StatesSite Not Available
Woodholme Gastroenterology Associates, PA
Baltimore, Maryland 21208
United StatesSite Not Available
Mid Atlantic Medical Research Centers
Hollywood, Maryland 20636
United StatesSite Not Available
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan 48047
United StatesSite Not Available
Kansas City, Missouri 67131
United StatesSite Not Available
Center for Digestive & Liver Diseases
Mexico, Missouri 65265
United StatesSite Not Available
St. Louis Center for Clinical Research
Saint Louis, Missouri 63128
United StatesSite Not Available
St. Louis Center for Clinical Research
St. Louis, Missouri 63128
United StatesSite Not Available
Central Jersey Primary Care Inc.
Elizabeth, New Jersey 07202
United StatesSite Not Available
empty
Ocean, New Jersey 07712
United StatesSite Not Available
Ocean City, New Jersey 07712
United StatesSite Not Available
New York, New York 10128
United StatesSite Not Available
VA Medical Center
Syracuse, New York 13210
United StatesSite Not Available
Upstate Gastroenterology Associates, PC
Troy, New York 12180
United StatesSite Not Available
LeBauer Research Associates, PA
Greensboro, North Carolina 27265
United StatesSite Not Available
Bethany Medical Center
High Point, North Carolina 27262
United StatesSite Not Available
Boice-Willis Clinic
Rocky Mount, North Carolina 27804
United StatesSite Not Available
Consultants for Clinical Research, Inc.
Cincinnati, Ohio 45219
United StatesSite Not Available
Avamar Center for Gastroenterology, Inc.
Warren, Ohio 44484
United StatesSite Not Available
Charleston Gastroenterology Specialists, LLC
Charleston, South Carolina 29414
United StatesSite Not Available
Hillcrest Clinical Research LLC
Simpsonville, South Carolina 29681
United StatesSite Not Available
Gastroenterology Associates
Kingsport, Tennessee 37660
United StatesSite Not Available
Gastrointestinal Associates
Knoxville, Tennessee 37909
United StatesSite Not Available
Memphis Gastroenterology Group
Memphis, Tennessee 38210
United StatesSite Not Available
Nashville Medical Research Institute
Nashville, Tennessee 37205
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77030
United StatesSite Not Available
Houston Digestive Disease Clinic
Houston, Texas 77090
United StatesSite Not Available
NationsMed Clinical Research
Houston, Texas 77034
United StatesSite Not Available
Gastroenterology Associates of Tidewater
Chesapeake, Virginia 23320
United StatesSite Not Available
Seattle Gastroenterology Associates
Seattle, Washington 98133
United StatesSite Not Available
Eastern Washington Clinical Research Center
Spokane, Washington 99204
United StatesSite Not Available
Spokane Digestive Disease Center Research
Spokane, Washington 99204
United StatesSite Not Available
Tacoma Digestive Disease Research Center
Tacoma, Washington 98405
United StatesSite Not Available
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