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

Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00255164
First received: November 15, 2005
Last updated: February 1, 2012
Last verified: February 2012

November 15, 2005
February 1, 2012
January 2006
November 2006   (final data collection date for primary outcome measure)
  • Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
- Percentage of subjects who maintained complete healing of erosive esophagitis over 6 months as assessed by endoscopy.
Complete list of historical versions of study NCT00255164 on ClinicalTrials.gov Archive Site
  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ 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 reported.
  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ 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 Without Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ 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 as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ 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 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.
Not Provided
Not Provided
 
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
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

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).

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 (this study, NCT00255164) and T-EE04-087 (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.

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 for up to six months.
    Other Names:
    • TAK-390MR
    • Kapidex
    • Dexilant
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
451
November 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255164
T-EE04-086, U1111-1114-1355
No
Takeda
Takeda
Not Provided
Study Director: Medical Director Takeda
Takeda
February 2012

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