SC12267 (4SC-101) for Treatment of Patients With Inflammatory Bowel Disease (ENTRANCE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00820365|
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : May 18, 2011
This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16 sites in Bulgaria, Germany and Romania.
A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for 12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up visit will be performed 4 weeks after study drug discontinuation or earlier in case of relapse during follow up. Total study duration will be up to 36 (+2) weeks.
There will be 8 study visits: one screening visit, 6 visits during the treatment period and one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10, Week 20 (+1) and Week 36 (+2).
The duration of the entire study (first patient in till last patient out) is expected to be about 13 months.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease (IBD)||Drug: SC12267 (4SC-101)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||March 2011|
- Drug: SC12267 (4SC-101)
Peroral administration of SC12267 (4SC-101) in patients with Inflammatory Bowel Disease over 12 weeks.
- Efficacy of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) after a 12 week therapy as measured by the number of patients with complete or partial response. [ Time Frame: after a 12 week therapy ]
- The secondary objective of this study is to evaluate the safety and tolerability of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with CD or UC and to explore plasma levels (trough values) of SC12267 (4SC-101). [ Time Frame: after a 12 week therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820365
|Tokuda Hospital Gastroenterology Division Internal Medicine Department|
|Sofia, Bulgaria, 1407|
|UMHAT "Sv. Ivan Rilski" Gastroenterology Clinic|
|Sofia, Bulgaria, 1431|
|UMHAT "Tsaritsa Ioanna" - ISUL Gastroenterology Clinic|
|Sofia, Bulgaria, 1527|
|Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum|
|Klinikum der Ruhr-Universität Bochum, St. Josef-Hospital, I. Medizinische Klinik|
|Universitätsklinikum Freiburg, Gastroenterologie, Hepatologie, Endokrinologie und Klinische Infektiologie|
|Schwerpunktpraxis für chronisch entzündliche Darmerkrankungen|
|Gastroenterologische Gemeinschaftspraxis Herne|
|Universitätsklinikum Schleswig-Holstein Campus Lübeck|
|Technische Universität München II. Medizinische Klinik des Klinikums rechts der Isar|
|Gastroenterologische Gemeinschaftspraxis am Germania-Campus|
|Universitätsklinikum Regensburg Klinik und Poliklinik für Innere Medizin I|
|Stuttgart, Germany, 70376|
|Elias University Emergency Hospital|
|Bucuresti, Romania, 011461|
|Colentina Clinical Hospital|
|Bucuresti, Romania, 020125|
|University Emergency Hospital|
|Bucuresti, Romania, 050098|
|Principal Investigator:||Klaus Herrlinger, Prof.||Robert Bosch Krankenhaus, Stuttgart, Germany|