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Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
This study has been completed.
First Received: May 2, 2006   Last Updated: April 16, 2009   History of Changes
Sponsored by: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00321984
  Purpose

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).


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

MedlinePlus related topics: GERD Heartburn
Drug Information available for: Dexlansoprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

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 ]
  • 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 ]

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

Enrollment: 947
Study Start Date: June 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
2: Experimental Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
3: Placebo Comparator Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Detailed 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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321984

  Show 153 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:
No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers: T-GD05-137, EUDRA CT# 2006-000420-13
Study First Received: May 2, 2006
Results First Received: February 26, 2009
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00321984     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Gastroesophageal Reflux Disease(GERD)
Heartburn

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Pyrosis
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases
Heartburn
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on May 07, 2009