Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00251758
First received: November 8, 2005
Last updated: May 12, 2010
Last verified: May 2010
  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 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:


Further study details as provided by Takeda:

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
Investigators
Study Director: Medical Director Takeda
  More Information

Additional Information:
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:
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 April 14, 2014