Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251745
• Other study ID #: T-GD04-082
• Secondary ID: U1111-1114-0144
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2005
• Last updated: April 25, 2011
• Start date: December 2005
• Est. completion date: May 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 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).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 908
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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 60 mg, capsules, orally, once daily for 4 weeks.
• Dexlansoprazole MR
Dexlansoprazole MR 90 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 (1)

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 FDA Safety Alerts and Recalls refer to this link
•   For the Dexilant Package Insert refer to this link