Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321984
• Other study ID #: T-GD05-137
• Secondary ID: 2006-000420-13U1
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2006
• Last updated: April 25, 2011
• Start date: June 2006
• Est. completion date: December 2006

Study information

• Verified date: April 2011
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of Dexlansoprazole modified release (MR) (30 mg once daily [QD] or 60 mg QD) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (GERD).

Description:

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 Dexlansoprazole MR (30 mg QD and 60 mg QD) 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 nonerosive GERD. Approximately 900 subjects will be enrolled at approximately 200 United States (US) and potentially ex-US 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 947
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn).

• Subject has a history of episodes of heartburn for 6 months or longer prior to Screening.

• Subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to Day -1.

Exclusion Criteria:

• Endoscopic Barrett's esophagus and/or definite dysplastic changes. History of dilatation of esophageal strictures.

• Subjects with erosive esophagitis (EE) as shown by endoscopy.

• Evidence of uncontrolled systemic disease. Co-existing diseases affecting the esophagus. Current or history of Zollinger-Ellison syndrome.

• Subject has abnormal laboratory values.

• Subjects with active gastric or duodenal ulcers within 4 weeks of the first dose.

• Subject known to have acquired immunodeficiency syndrome (AIDS).

• Known hypersensitivity to any proton pump inhibitor (PPI), any component of Dexlansoprazole MR, or antacid.

• Use of prescription or non-prescription PPIs, histamine (H2) receptor antagonists, or sucralfate.

• 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.

• Subjects who cannot discontinue the use of misoprostol or prokinetics

• Need for continuous anticoagulant therapy.

• Females who are pregnant or lactating.

• History of gastrointestinal surgery except for simple oversew of ulcer.

• History of cancer within 3 years prior to screening.

• Subject has participated in a previous Dexlansoprazole study.

• Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
• Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
• Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fass R, Chey WD, Zakko SF, Andhivarothai N, Palmer RN, Perez MC, Atkinson SN. Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non-erosive reflux disease. Aliment Pharmacol The — View Citation

Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24. Rev — View Citation

Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median	The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.	4 weeks	No
Primary	Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean	The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.	4 weeks	No
Secondary	Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median	The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.	4 weeks	No
Secondary	Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean	The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.	4 weeks	No

External Links

•   For the Dexilant package insert refer to this link
•   For the FDA safety alerts and recalls refer to this link