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

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00321984
First received: May 2, 2006
Last updated: April 25, 2011
Last verified: April 2011
History of Changes
  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 3

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 (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn
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: 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
Experimental: Dexlansoprazole MR 30 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
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
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, 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:
For the Dexilant package insert refer to this link  This link exits the ClinicalTrials.gov site
For the FDA safety alerts and recalls refer to this link  This link exits the ClinicalTrials.gov site

Publications:
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 nonerosive reflux disease. Aliment Pharmacol Ther 2009;29:(12):1261-1272.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00321984     History of Changes
Other Study ID Numbers: T-GD05-137, 2006-000420-13, U1111-1114-1935
Study First Received: May 2, 2006
Results First Received: February 26, 2009
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

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