11,385
Participants
Start Date
October 25, 2021
Primary Completion Date
July 31, 2022
Study Completion Date
July 31, 2022
PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)
"The 5-ASAs of interest in the study are mesalazine (5-ASA); sulfasalazine (5-ASA+sulfapyridine); and balsalazide (5-ASA) and will be grouped together as 5-ASA. For sulfasalazine and balsalazide, the equivalent dose to 5-ASA will be calculated as: balsalazide 6.75g is equivalent to 2.4g of mesalamine; and Sulfasalazine 4g is equivalent to 1.6g of mesalamine.~The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy."
Severance Hospital, Seoul
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY