Phase
Condition
Ulcerative Colitis
Bowel Dysfunction
Ulcers
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients fulfilling the following criteria are eligible for participation in thestudy:
Male and female patients, 18-75 years old, who are able to understand andvoluntarily provide written informed consent.
Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baselinein the endoscopy score without any sign of mucosal friability (score 0 formucosal appearance).
Patients who have completed all End of Study assessments for the CB-01-02/01,CB-01-02/02 and CB-01-02/06 studies.
Females of child-bearing potential must have had a serum pregnancy test performedat the End of Study visit of the parent studies and must use an acceptablecontraceptive method throughout the study treatment period.
Exclusion
Exclusion Criteria:
Patients who meet any of the following criteria at screening visit are to be excludedfrom study participation:
Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
Subjects who did not achieve induction of remission according to the primaryendpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e.clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 forrectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in theendoscopy score without any sign of mucosal friability [score 0 for mucosalappearance]).
Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.
Study Design
Connect with a study center
Santarus Clinical Investigational Site 6014
Vancouver, British Columbia V6Z 2K5
CanadaSite Not Available
Santarus Clinical Investigational Site 6008
Victoria, British Columbia V8R 1J8
CanadaSite Not Available
Santarus Clinical Investigational Site 6004
Richmond Hill, Ontario L4B 3P8
CanadaSite Not Available
Santarus Clinical Investigational Site 6006
Toronto, Ontario M3N 2V7
CanadaSite Not Available
Santarus Clinical Investigational Site 6013
Longueuil, Quebec J4N 1E1
CanadaSite Not Available
Santarus Clinical Investigational Site 5051
Huntsville, Alabama 35801
United StatesSite Not Available
Santarus Clinical Investigational Site 5088
Tucson, Arizona 85712
United StatesSite Not Available
Santarus Clinical Investigational Site 5088
Tuscon, Arizona 85712
United StatesSite Not Available
Santarus Clinical Investigational Site 5044
Anaheim, California 92801
United StatesSite Not Available
Santarus Clinical Investigational Site 5087
Lakewood, California 90712
United StatesSite Not Available
Santarus Clinical Investigational Site 5033
Los Angeles, California 90045
United StatesSite Not Available
Santarus Clinical Investigational Site 5070
Palm Springs, California 92262
United StatesSite Not Available
Santarus Clinical Investigational Site 5067
San Diego, California 92101
United StatesSite Not Available
Santarus Clinical Investigational Site 5064
Lakewood, Colorado 80215
United StatesSite Not Available
Santarus Clinical Investigational Site 5089
Boynton Beach, Florida 33426
United StatesSite Not Available
Santarus Clinical Investigational Site 5041
Hollywood, Florida 33021
United StatesSite Not Available
Santarus Clinical Investigational Site 5055
New Smyrna Beach, Florida 32168
United StatesSite Not Available
Santarus Clinical Investigational Site 5074
Port Orange, Florida 32127
United StatesSite Not Available
Santarus Clinical Investigational Site 5009
Tampa, Florida 33613
United StatesSite Not Available
Santarus Clinical Investigational Site 5032
Tampa, Florida 33607
United StatesSite Not Available
Santarus Clinical Investigational Site 5047
Winter Park, Florida 32789
United StatesSite Not Available
Santarus Clinical Investigational Site 5003
Zephyrhills, Florida 33542
United StatesSite Not Available
Santarus Clinical Investigational Site 5016
Atlanta, Georgia 30312
United StatesSite Not Available
Santarus Clinical Investigational Site 5056
Columbus, Georgia 31904
United StatesSite Not Available
Santarus Clinical Investigational Site 5068
Evanston, Illinois 60201
United StatesSite Not Available
Santarus Clinical Investigational Site 5008
Metairie, Louisiana 70006
United StatesSite Not Available
Santarus Clinical Investigational Site 5090
Annapolis, Maryland 21401
United StatesSite Not Available
Santarus Clinical Investigational Site 5025
Baltimore, Maryland 21229
United StatesSite Not Available
Santarus Clinical Investigational Site 5092
Hollywood, Maryland 20636
United StatesSite Not Available
Santarus Clinical Investigational Site 5077
Prince Frederick, Maryland 20678
United StatesSite Not Available
Santarus Clinical Investigational Site 5010
Chesterfield, Michigan 48047
United StatesSite Not Available
Santarus Clinical Investigational Site 5006
Troy, Michigan 48098
United StatesSite Not Available
Santarus Clinical Investigational Site 5004
Wyoming, Michigan 49519
United StatesSite Not Available
Santarus Clinical Investigational Site 5005
Marlton, New Jersey 08053
United StatesSite Not Available
Santarus Clinical Investigational Site 5011
Great Neck, New York 11021
United StatesSite Not Available
Santarus Clinical Investigational Site 5101
New York, New York 10016
United StatesSite Not Available
Santarus Clinical Investigational Site 5020
Pittsford, New York 14534
United StatesSite Not Available
Santarus Clinical Investigational Site 5096
Fayetteville, North Carolina 28304
United StatesSite Not Available
Santarus Clinical Investigational Site 5058
Huntersville, North Carolina 28078
United StatesSite Not Available
Santarus Clinical Investigational Site 5091
New Bern, North Carolina 28562
United StatesSite Not Available
Santarus Clinical Investigational Site 5045
Cincinnati, Ohio 45219
United StatesSite Not Available
Santarus Clinical Investigational Site 5078
Dayton, Ohio 45440
United StatesSite Not Available
Santarus Clinical Investigational Site 5001
Yukon, Oklahoma 73099
United StatesSite Not Available
Santarus Clinical Investigational Site 5066
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Santarus Clinical Investigational Site 5065
Pottstown, Pennsylvania 19464
United StatesSite Not Available
Santarus Clinical Investigational Site 5035
Sayre, Pennsylvania 18840
United StatesSite Not Available
Santarus Clinical Investigational Site 5021
Austin, Texas 78745
United StatesSite Not Available
Santarus Clinical Investigational Site 5019
Houston, Texas 77090
United StatesSite Not Available
Santarus Clinical Investigational Site 5036
Houston, Texas 77090
United StatesSite Not Available
Santarus Clinical Investigational Site 5076
Houston, Texas 77034
United StatesSite Not Available
Santarus Clinical Investigational Site 5063
Irving, Texas 75061
United StatesSite Not Available
Santarus Clinical Investigational Site 5072
Kingwood, Texas 77339
United StatesSite Not Available
Santarus Clinical Investigational Site 5054
La Porte, Texas 77571
United StatesSite Not Available
Santarus Clinical Investigational Site 5054
LaPort Texas, Texas 77571
United StatesSite Not Available
Santarus Clinical Investigational Site 5030
Lewisville, Texas 75057
United StatesSite Not Available
Santarus Clinical Investigational Site 5093
Plano, Texas 75075
United StatesSite Not Available
Santarus Clinical Investigational Site 5079
San Antonio, Texas 78258
United StatesSite Not Available
Santarus Clinical Investigational Site 5100
San Antonio, Texas 78229
United StatesSite Not Available
Santarus Clinical Investigational Site 5015
Salt Lake City, Utah 84107
United StatesSite Not Available
Santarus Clinical Investigational Site 5097
Christianburg, Virginia 24073
United StatesSite Not Available
Santarus Clinical Investigational Site 5097
Christiansburg, Virginia 24073
United StatesSite Not Available
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