Clinical Usefulness of TU-199, a New Anti-ulcer Agent(Benatoprazole), in the treatment of Peptic Ulcer. A Double Blind, Randomized, Comparative Study with Omeprazole.
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Accession number;99A0447093
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| Title;Clinical Usefulness of TU-199, a New Anti-ulcer Agent(Benatoprazole), in the treatment of Peptic Ulcer. A Double Blind, Randomized, Comparative Study with Omeprazole. |
| Author;
NIWA HIROFUMI
(Teikyo Univ.)
MASAMUNE OSAMU
(Akita Univ., Sch. of Med.)
MORI HARUKI
(Tokyo Women's Medical College, Second Hospital)
SAIGENJI KATSUNORI
(Kitasato Univ., East Hosp.)
MIWA TAKESHI
(Tokai Univ., Sch. of Med.)
KAMADA TAKENOBU
(Osaka Rosai Hosp.)
KAJIYAMA GORO
(Hiroshima Univ., Sch. of Med.)
HAYAKAWA AKIRA
(Japan Red Cross Soc. Nagasaki Atom. Bomb Hosp.)
GUNJI ATSUAKI
(Univ. of Tokyo, Fac. of Med.)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.15;NO.3;PAGE.465-497(1999)
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| Figure&Table&Reference;FIG.3, TBL.25, REF.37 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;TU-199(Benatoprazole) is a newly synthesized imidazopyridine which is a potent inhibitor of gastric acid secretion with its action upon H+, K+-ATPase(proton pump inhibitor; PPI). A double blind randomized comparative study of TU-199 was conducted in the treatment of gastric ulcer and duodenal ulcer using omeprazole(OPZ) as a control in order to evaluate its efficacy and safety. The patients who entered the study had gastric ulcer or duodenal ulcer with endoscopic active stages(A1 or A2), and were administrated TU-199(10mg once daily) or OPZ(20mg once daily) for 8 or 6 weeks, respectively, using the double dummy method. 1) In the present study, TU-199 and OPZ were administered to 139 and 147 gastric ulcer patients(total: 286) and 131 and 130 duodenal ulcer patients(total: 261), respectively. The final global improvement rating was evaluated in 116 and 112 gastric ulcer patients and 101 and 101 duodenal ulcer patients in the TU and OPZ groups, respectively. When gastric ulcer patients included in the analysis of final global improvement rating were observed, imbalance(p<0.15) was noted between the two groups with respect to the past history of ulcer(initial, recurrent or unknown). However, this imbalance did not affect the results of the analysis. No inter-group imbalance was observed with respect to any other background factor. 2) Cure rates as observed by endoscopic findings(primary endpoint) of the gastric ulcer patients at week 8 were 90.6% and 89.4% for the TU and OPZ groups, respectively, and those of the duodenal ulcer patients at week 6 were 98.0% and 96.0%, showing high scores and to be statically comparable. Cure rates of gastric ulcer at week 4 and duodenal ulcer at week 3 were 63.2% and 80.8%, respectively, in the TU group, and those in the OPZ group were 59.0% and 79.4%, showing no significant difference. 3) In signs and symptoms there were no significant differences at the improvement rates between the two groups.... (author abst.) |
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