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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
ClinicalTrials.gov Identifier:
NCT00321984
First received: May 2, 2006
Last updated: April 25, 2011
Last verified: April 2011

May 2, 2006
April 25, 2011
June 2006
December 2006   (final data collection date for primary outcome measure)
  • 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.
Mean percentage of days without daytime or nighttime heartburn over 4 weeks as assessed by daily electronic diary.
Complete list of historical versions of study NCT00321984 on ClinicalTrials.gov Archive Site
  • 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.
Mean percentage of days without nighttime heartburn over 4 weeks as assessed by daily electronic diary.
Not Provided
Not Provided
 
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
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)

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 30 mg, capsules, orally, once daily for 4 weeks.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • Drug: Placebo
    Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
  • Experimental: Dexlansoprazole MR 30 mg QD
    Intervention: Drug: Dexlansoprazole MR
  • Experimental: Dexlansoprazole MR 60 mg QD
    Intervention: Drug: Dexlansoprazole MR
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
947
December 2006
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00321984
T-GD05-137, 2006-000420-13, U1111-1114-1935
No
Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
Takeda
Not Provided
Study Director: Medical Director Takeda
Takeda
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP