Funded in full by Dr. Falk Pharma GmbH, Freiburg, Germany.
Original Clinical Article
Article first published online: 22 MAR 2010
Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 16, Issue 11, pages 1947–1956, November 2010
How to Cite
Andus, T., Kocjan, A., Müser, M., Baranovsky, A., Mikhailova, T. L., Zvyagintseva, T. D., Dorofeyev, A. E., Lozynskyy, Y. S., Cascorbi, I., Stolte, M., Vieth, M., Dilger, K., Mohrbacher, R. and Greinwald, R. (2010), Clinical trial: A novel high-dose 1 g mesalamine suppository (salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis. Inflamm Bowel Dis, 16: 1947–1956. doi: 10.1002/ibd.21258
The coauthors not listed below have declared no conflict of interest: Tilo Andus, Manfred Stolte, and Michael Vieth have served as speakers and consultants for Dr. Falk Pharma, Freiburg, Germany. Ingolf Cascorbi has received research funding from Dr. Falk Pharma, Freiburg, Germany. Tatyana D. Zvyagintseva has served as a speaker, a consultant, and an advisory board member for Dr. Falk Pharma, and has received research funding from Kharkov Medical Academy of Postgraduated Education. Andrey E. Dorofeyev has served as a speaker, a consultant, and an advisory board member for Dr. Falk Pharma, and has received research funding from Donetsk National Medical University. Karin Dilger, Ralf Mohrbacher, and Roland Greinwald are employees of Dr. Falk Pharma, Freiburg, Germany.
Members of the International Salofalk Suppository OD Study Group are listed in the Appendix
- Issue published online: 22 MAR 2010
- Article first published online: 22 MAR 2010
- Manuscript Received: 19 JAN 2010
- Manuscript Accepted: 19 JAN 2010
- distal ulcerative colitis
Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository.
This was a single-blind (investigator-blinded), randomized, multicenter, comparative, Phase III clinical trial. Patients with mild to moderately active ulcerative proctitis inserted either one mesalamine 1 g suppository at bedtime or one mesalamine 0.5 g suppository thrice daily over a 6-week period. The primary endpoint was rate of remission (Disease Activity Index below 4).
In all, 354 patients were evaluable for safety and per-protocol analysis. The new regimen demonstrated noninferiority: The percentage of patients with remission was 87.9% for the once-daily 1 g mesalamine suppository and 90.7% for the thrice-daily 0.5 g mesalamine suppository. Each regimen resulted in prompt cessation of clinical symptoms (e.g., median time to ≤3 stools per day (all without blood): 5 days in the 1 g mesalamine once-daily and 7 days in the 0.5 g mesalamine thrice-daily group). Patients preferred applying suppositories once a day.
In active ulcerative proctitis the once-daily administration of a 1 g mesalamine suppository is as effective and safe, yet considerably more convenient, than the standard thrice-daily administration of a 0.5 g mesalamine suppository. (Inflamm Bowel Dis 2010)