Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00251758
Recruitment Status : Completed
First Posted : November 10, 2005
Results First Posted : March 23, 2009
Last Update Posted : May 18, 2010
Sponsor:
Information provided by:
Takeda

Tracking Information
First Submitted Date  ICMJE November 8, 2005
First Posted Date  ICMJE November 10, 2005
Results First Submitted Date  ICMJE February 26, 2009
Results First Posted Date  ICMJE March 23, 2009
Last Update Posted Date May 18, 2010
Study Start Date  ICMJE December 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2010)
  • Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [ Time Frame: 4 weeks ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2005)
- The mean percentage of days without daytime or nighttime heartburn over 4 weeks as assessed by daily electronic diary.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2010)
  • Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median [ Time Frame: 4 weeks ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2005)
- The mean percentage of days without nighttime heartburn over 4 weeks as assessed by daily electronic diary.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Official Title  ICMJE 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)
Brief Summary 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux Disease
Intervention  ICMJE
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 90 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.
Study Arms  ICMJE
  • Experimental: Dexlansoprazole MR 60 mg QD
    Intervention: Drug: Dexlansoprazole MR
  • Experimental: Dexlansoprazole MR 90 mg QD
    Intervention: Drug: Dexlansoprazole MR
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2009)
908
Original Enrollment  ICMJE
 (submitted: November 8, 2005)
750
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00251758
Other Study ID Numbers  ICMJE T-GD04-083
U1111-1114-1811 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Takeda
PRS Account Takeda
Verification Date May 2010

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