efficacy and safety of dexlansoprazole modified release formulation to treat heartburn

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to assess the efficacy and safety of daily treatment with dexlansoprazole modified release (mr) (60 mg or 90 mg once daily \[qd\]) compared to placebo qd in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (gerd).

this is a phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. this study will compare the efficacy of daily dexlansoprazole mr (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. the study is designed to evaluate symptom relief in subjects with symptomatic non-erosive gerd. approximately 450 subjects will be enrolled at approximately 120 u.s. and potentially ex u.s. sites. the study consists of two periods; a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks. because the development plan for dexlansoprazole mr was revised, the results of 2 identical studies, t-gd04-082 (this posting, nct00241745) and t-gd04-083 (nct00251758), were combined and analyzed as a single larger study referred to as study t-gd04-082. a total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into study t-gd04-082 and 492 subjects were enrolled into study t-gd04-083.

Eligibility criteria:
inclusion criteria: * subjects with non-erosive gastroesophageal reflux disease identifying their main symptom as heartburn. * history of episodes of heartburn for 6 months or longer prior to screening. * history of episodes of heartburn for 4 or more days during the 7 days prior to day -1 as recorded in the electronic diary. exclusion criteria: * use of prescription or non-prescription proton pump inhibitors (ppis), histamine (h2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study· * use of antacids (except for study supplied gelusil®). * use of drugs with significant anticholinergic effects. * need for continuous anticoagulant (blood thinner) therapy. * endoscopic barrett's esophagus and/or definite dysplastic changes in the esophagus. * history of dilatation of esophageal strictures, other than a schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter). * current or historical evidence of zollinger-ellison syndrome or other hypersecretory condition. * history of gastric, duodenal or esophageal surgery except simple oversew of an ulcer. * acute upper gastrointestinal (ugi) hemorrhage within 4 weeks of the screening endoscopy. * erosive esophagitis seen on endoscopy during study screening. * co-existing diseases affecting the esophagus. * abnormal laboratory values that suggest significant clinical disease. * known acquired immunodeficiency syndrome (aids) * females pregnant or lactating. * history of alcohol abuse. * history of cancer within 3 years prior to screening. * chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (nsaids) or cyclo-oxygenase-2 (cox-2) inhibitors * subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Keywords: non-erosive gastroesophageal reflux disease (gerd) heartburn