To gain access, data requestors must enter into a data access agreement with Pfizer. Abstract Introduction Reflux symptoms are frequently associated with esophageal acid exposure. over-the-counter (OTC) medications. We hypothesized that improved acid control would provide greater symptomatic improvement among individuals representative of an OTC populace. Methods This phase 4, single-center, randomized, double-blind, placebo-controlled study was conducted in subjects without Peiminine diagnosed gastroesophageal reflux disease or other gastrointestinal conditions who were experiencing frequent heartburn (?3 episodes/week;??2 nighttime episodes/week over recent 30?days) that was responsive to treatment. Subjects joined a 7-day run-in phase, received placebo BID (before breakfast and dinner), and completed symptom diaries. During the treatment phase, subjects received esomeprazole 20?mg BID, esomeprazole 20?mg then placebo, or placebo BID. Subjects underwent 24-h intragastric pH monitoring at baseline and day 14 and completed daily symptom diaries. Results In the per-protocol populace (values and 95% CIs. SAS? software (version 9.4; SAS Institute; Cary, NC, USA) was used to perform all statistical analyses. Results A total of 55 subjects were randomized to one of the three treatment arms; all 55 subjects were included in the FAS populace (Fig.?2). The PP populace included 39 subjects (16 subjects randomized to esomeprazole 20?mg/esomeprazole 20?mg, 18 subjects randomized to esomeprazole 20?mg/placebo, and 5 subjects randomized to placebo/placebo). Among those excluded from your PP populace, most were not evaluable because they required rescue medication for ?2?days during days 8C14 and thus ?2?days of diary data were set to be missing during that period, violating the PP populations definition. Owing to the nature of this proof-of-concept study, the PP populace was utilized for all endpoint analyses; only select analyses were performed around the FAS populace. Results of some FAS analyses, which included 12 placebo subjects, are also reported. Demographic Rabbit Polyclonal to PKR and baseline characteristics of the study populace were comparable among the three groups (Table?2). Open in a separate windows Fig.?2 Subject disposition. The per-protocol populace included only evaluable subjects, defined as subjects who completed the 14-day treatment phase, underwent and provided valid data for day-14 pH monitoring and completed??5?days of diary entries on each of days ??7 to ??1 and days 8C14. ESO esomeprazole, FAS full analysis set, PBO placebo, PP per-protocol Table?2 Demographic and baseline characteristics (%)?Female34 (61.8)11 (52.4)14 (63.6)9 (75.0)Age, years?Mean (SD)41.9 (10.5)41.6 (10.2)40.8 (11.0)44.7 (10.5)Race, (%)?White47 (85.5)17 (81.0)22 (100)8 (66.7)?Black4 (7.3)1 (4.8)0 (0)3 (25.0)?Other4 (7.3)3 (14.3)0 (0)1 Peiminine (8.3)Ethnicity, (%)?Hispanic/Latino4 (7.3)1 (4.8)3 (13.6)0 (0)Excess weight, kg?Mean (SD)94.9 (21.2)96.5 (19.1)93.0 (24.3)95.7 (20.1)Height, cm?Mean (SD)170.6 (10.4)171.0 (10.8)171.3 (11.2)168.7 (8.4)BMI, kg/m2?Mean (SD)32.5 (6.2)32.9 (5.0)31.5 (6.8)33.7 (7.2) Open in a separate windows body mass index, standard deviation Relationship Peiminine Between Intragastric pH and 24-h Heartburn Relief In the PP populace (body mass index, confidence interval, odds ratio Data are presented as *[OR (95% CI); value] or **[Coefficient (95% CI);Pvalue] aLogistic regression model with each parameter at day 14 as dependent variable and switch in percentage of time with intragastric pH? ?4 or switch in median intragastric pH as the indie variable, controlling for age, sex, and BMI bLinear regression model with each parameter at day 14 as dependent variable and switch in percentage of time with intragastric pH? ?4 or switch in median intragastric pH as the indie variable, controlling for age, sex, and BMI cNighttime heartburn is defined as an event that occurred during the time after the subject consumed their evening meal until the time they got up the next morning to start daily activities Open in a separate windows Fig.?4 Boxplot of change in percentage of time with intragastric pH? ?4 for subjects with complete resolution of 24-h heartburn vs. no resolution of 24-h.