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Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00251693
First received: November 8, 2005
Last updated: February 1, 2012
Last verified: February 2012

November 8, 2005
February 1, 2012
December 2005
January 2007   (final data collection date for primary outcome measure)
  • Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
  • Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
-Percentage of subjects with complete healing of erosive esophagitis over 8 weeks as assessed by endoscopy.
Complete list of historical versions of study NCT00251693 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
  • Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
  • Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
  • Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
  • - Percentage of subjects with complete healing of erosive esophagitis over 4 weeks as assessed by endoscopy.
  • - Percentage of subjects with baseline esophagitis grade C or D combined who have complete healing of erosive esophagitis over 8 weeks as assessed by endoscopy.
Not Provided
Not Provided
 
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis

The purpose of this study is to assess the efficacy and safety of 8 weeks of once-daily (QD) treatment with dexlansoprazole modified release (MR) 60 mg or 90 mg or lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8-week treatment period. This study will compare the efficacy of dexlansoprazole MR (60 mg QD and 90 mg QD) with that of lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease-related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last 8 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
  • Esophagitis, Reflux
  • Esophagitis, Peptic
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 60 mg, capsules, orally, once daily (QD) for up to 8 weeks.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • Drug: Lansoprazole
    Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
    Other Names:
    • Prevacid
    • AG-1749
  • Experimental: Dexlansoprazole MR 60 mg QD
    Intervention: Drug: Dexlansoprazole MR
  • Experimental: Dexlansoprazole MR 90 mg QD
    Intervention: Drug: Dexlansoprazole MR
  • Active Comparator: Lansoprazole 30 mg QD
    Intervention: Drug: Lansoprazole

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2038
January 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D)

Exclusion Criteria:

  • Subject has a positive Campylobacter-like organisms (CLO) test for Helicobacter (H.) pylori.
  • Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists or sucralfate, drugs with significant anticholinergic effects, misoprostol or prokinetics
  • Use of antacids [except for study supplied Gelusil®]
  • Need for continuous anticoagulant therapy (blood thinners)
  • Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
  • History of dilatation of esophageal strictures, other than 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.
  • Acute upper gastrointestinal 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,   Australia,   Bulgaria,   Canada,   Czech Republic,   Germany,   Hungary,   India,   Latvia,   Lithuania,   New Zealand,   Peru,   Poland,   Slovakia,   South Africa
 
NCT00251693
T-EE04-084, U1111-1113-9373
No
Takeda
Takeda
Not Provided
Study Chair: Medical Director Takeda
Takeda
February 2012

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