Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn - Full Text View

Purpose

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).

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Dexlansoprazole MR Drug: Placebo	Phase 3

Takeda Global Research & Development Center, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	908
Study Start Date:	December 2005
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dexlansoprazole MR 60 mg QD	Drug: Dexlansoprazole MR Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks. Other Names: TAK-390MR Kapidex Dexilant
Experimental: Dexlansoprazole MR 90 mg QD	Drug: Dexlansoprazole MR Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks. Other Names: TAK-390MR Kapidex Dexilant
Placebo Comparator: Placebo	Drug: Placebo Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251758

Show 99 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

For the Dexilant Package Insert refer to this link This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to this link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00251758 History of Changes
Other Study ID Numbers:	T-GD04-083, U1111-1114-1811
Study First Received:	November 8, 2005
Results First Received:	February 26, 2009
Last Updated:	May 12, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013