Misoprostol in the treatment of duodenal ulcers in the people's Republic of China: A comparative, double‐blind, multicenter study

Abstract

In recent years, it has become mandatory for many pharmaceutical companies to conduct country‐specific clinical studies which are needed for obtaining regulatory approvals for their drugs. Such studies are important to delineate possible racial or environmental (lifestyle) differences which could not have been predicted from data obtained in other populations. A double‐blind, randomized, double‐dummy, multiclinic, comparative trial examined the tolerance and efficacy of misoprostol (200 μg QID) and cimetidine (200 mg QID) for the treatment of duodenal ulcers in the People's Republic of China. The trial characteristics and monitoring complied with the standards in the United States of America and the People's Republic of China. Two hundred consenting outpatients of either sex, aged 18–75 years, who had duodenal ulcers (not less than 0.3 cm in longest diameter and not more than 2 ulcers) were enrolled. Endoscopy, physical examination, and laboratory assessments wereperformed on entry and after 4 weeks of treatment. The effects of the treatment on ulcer healing, dyspeptic symptoms, tolerance, and adverse drug reactions were determined. Both treatment groups were well matched for demographic characteristics and disease severity at entry to the study. Misoprostol showed equal efficacy to cimetidine in inducing ulcer healing (60.7% vs. 67.9% for misoprostol and cimetidine, respectively, P > 0.05) and resolving dyspeptic pain. The extent of duodenal ulcer healing achieved by misoprostol in this study is essentially similar to the ulcer healing rates noted in many other worldwide studies, indicating the absence of racial differences in response to misoprostol. The adverse effects observed for misoprostol and cimetidine were also very similar. Both drugs were very well tolerated; however, slightly more patients experienced transient diarrhea with misoprostol (6.4%) than with cimetidine (3.8%). In conclusion, this trial supports the world‐ wide efficacy and tolerance of misoprostol for the treatment of duodenal ulcers and indi‐ cates the absence of racial influences on the safety and efficacy of misoprostol. © 1992 Wiley‐Liss, Inc.

Design And Optimization Studies Of Tablet In Tablet Formulation Of Diclofenac And Misoprostol: Application Of Response Surface Methodology And Compressional Behaviour Strategy

“…Misoprostol is recommended by FDA for the management of NSAID-induced gastric and duodenal ulcers. [14]. The misoprostol formulation is difficult to formulate due to its viscous liquid form and instable nature at room temperature.…”