Efficacy of ebrotidine and ranitidine in the treatment of benign gastric ulcer.
This is a phase III, randomized, double-blind, clinical trial with two parallel groups of 50 patients to assess the efficacy of ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]ethyl ] amino]methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) 800 mg and ranitidine 300 mg as a single evening dose in the treatment of benign gastric peptic ulcer. Prior to treatment, an endoscopy was performed to detect ulcer lesions and to discard malignancies. Clinical and endoscopic examinations were performed at 6, 9 and 12 weeks. Healing rates were significant for both treatments at week 6, while at week 12 there was statistical significance for ebrotidine as compared to ranitidine (96% vs 88% in the intention-to-treat analysis and 98% vs 87.5% in the per protocol analysis). Decrease in ulcer diameter was significant for both treatments at week 6, and for ebrotidine versus ranitidine at weeks 9 and 12. The overall improvement of symptoms was higher with ebrotidine, which was already significant at week 6. Safety was considered to be excellent, since no significant adverse events were reported for the patients included in the study.
Gedliczka
O
O
2nd Surgical Department, School of Medicine, Jagiellonian University, Cracow, Poland.
Bobrzynski
A
A
Rembiasz
K
K
Fillat
O
O
Torres
J
J
Herrero
E
E
Márquez
M
M
Camps
F
F
Ortiz
J A
JA
D000328:Adult; D000368:Aged; D001557:Benzenesulfonates / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy*; D013844:Thiazoles / Q000627:therapeutic use*
D001557:Benzenesulfonates; D006635:Histamine H2 Antagonists; D013844:Thiazoles; D011899:Ranitidine; C075156:ebrotidine