Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 8, 2005
May 12, 2010
December 2005
May 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.
- The 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 NCT00251758 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.
- The 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 Heartburn
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)

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).

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.

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 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
908
May 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00251758
T-GD04-083, U1111-1114-1811
No
Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
Takeda
Not Provided
Study Director: Medical Director Takeda
Takeda
May 2010

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