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Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

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ClinicalTrials.gov Identifier: NCT00255151
Recruitment Status : Completed
First Posted : November 17, 2005
Results First Posted : August 28, 2009
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE November 15, 2005
First Posted Date  ICMJE November 17, 2005
Results First Submitted Date  ICMJE February 20, 2009
Results First Posted Date  ICMJE August 28, 2009
Last Update Posted Date February 3, 2012
Study Start Date  ICMJE January 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
  • Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 6 months ]
    Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
  • Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method [ Time Frame: 6 months ]
    Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
- Percentage of subjects who maintained complete healing of erosive esophagitis over 6 months as assessed by endoscopy.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ]
    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 reported.
  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ]
    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 Without Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ]
    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 as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ]
    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 15, 2005)
  • - Mean percentage of days without daytime or nighttime heartburn over 6 months as assessed by daily electronic diary.
  • - Mean percentage of days without nighttime heartburn over 6 months 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 Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
Official Title  ICMJE A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
Brief Summary The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
Detailed Description

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.

Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (NCT00255164) and T-EE04-087 (this study, NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.

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
  • Esophagitis, Reflux
  • Esophagitis, Peptic
Intervention  ICMJE
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
    Other Names:
    • TAK-390MR
    • Dexilant
    • Kapidex
  • Drug: Dexlansoprazole MR
    Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • Drug: Placebo
    Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
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 * Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.

*   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: July 20, 2009)
451
Original Enrollment  ICMJE
 (submitted: November 15, 2005)
360
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.

Exclusion Criteria:

  • Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
  • Use of antacids (except for study supplied) throughout the study.
  • Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • Need for continuous anticoagulant therapy.
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 NCT00255151
Other Study ID Numbers  ICMJE T-EE04-087
U1111-1114-1767 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Medical Director Takeda
PRS Account Takeda
Verification Date February 2012

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