The list of kit numbers together with the respective substance order was inaccessible for the investigator and patients and was stored by the kit producer until the finish of your study. Within this double blind style, throughout the very first study phase 23 on the subjects obtained omeprazole and 25 the pla cebo. Within the second phase individuals were crossed more than for the other arm. A washout period between the two remedy phases was not applied. The sufferers have been asked to take capsules for 14 days, twice a day, 30 min utes before a meal from their respective box. Individuals took the first dose in the advised substance on the evening with the randomization day and the last dose on the morning in the day on the evaluation. In addition, sufferers continued taking stable doses of previously pre scribed drugs, which includes aspirin.
Clopidogrel was not recom mended for any from the individuals. In addition, no study parti cipant changed smoking habits, alcohol drinking status or life style. The sufferers were allowed to take short acting antacids or selleckchem Maraviroc nitroglycerin as rescue medication and were asked to note such events in a diary. Through the study each of the sufferers had been asked to com plete the study diary assigned to them. They reported daily the quantity and severity of chest pain episodes, the circumstances from the appearance on the pain, the necessity for taking nitroglycerin along with the quantity of tablets taken per day, the presence of heartburn episodes and the want to take antacid, the appearance of adverse reactions, therapy tolerance and the score for their common feeling in accordance having a 10 point scale.
Furthermore, at the finish from the investigation phase, the SF 36 questionnaire was completed and also a treadmill strain test performed by each patient. Ethics The study protocol was authorized find more information by the local Bioethics Committee in the Nicolaus Copernicus University, Col legium Medicum in Bydgoszcz in Poland. All subjects gave their written informed consent before their inclu sion within the study. All procedures were conducted in compliance with the Declaration of Helsinki. Statistical analysis was performed applying a licensed version of statistical software program STATISTICA PL 9. 0 for Windows. Energy considerations indicated that a sample size of no less than 23 persons was essential. The outcomes have been pre sented as the imply or as a topic quantity and percentage.
Before the analysis, a test for the carryover impact of every single well being idea defined in the SF 36 survey applying a two stage Grizzle model was performed. The remedy influence was esti mated based on intention to treat evaluation guidelines. Nonetheless, because of the lack of a washout period, some doubts as to whether or not a cross over design will be appropriate in HRQL studies, and to exclude possible carryover effects on data interpretation, the outcomes pre sentation has been limited only to these data obtained from the 1st investigation phase, as within the randomized double blind, placebo controlled, parallel study style.