Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Takeda

Status and phase

Completed

Phase 3

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: Dexlansoprazole MR

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00251758

T-GD04-083

U1111-1114-1811 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

This is a Phase 3, randomized, double-blind, multi-center, 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 (NCT00241745) and T-GD04-083 (this posting, 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.

Enrollment

908 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
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
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
Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy