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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00321737
First received: May 2, 2006
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).


Condition Intervention Phase
Esophagitis, Reflux
Esophagitis, Peptic
Drug: Dexlansoprazole MR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 445
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexlansoprazole MR 30 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Experimental: Dexlansoprazole MR 60 mg QD Drug: Dexlansoprazole MR
Dexlansoprazole MR 60 mg, orally, once daily for up to six months.
Other Names:
  • TAK-390MR
  • Kapidex
  • Dexilant
Placebo Comparator: Placebo Drug: Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Detailed Description:

This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • Use of drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
  • Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors.
  • Need for continuous anticoagulant therapy.
  • Evidence of uncontrolled systemic disease.
  • Subjects who have participated in either maintenance study (T-EE04-086 [NCT00255164] or T-EE04-087 [NCT00255151]).
  • Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00321737

  Show 98 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Medical Director Takeda
  More Information

Additional Information:
Publications:
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00321737     History of Changes
Other Study ID Numbers: T-EE05-135, 2006-000419-90, U1111-1113-9433
Study First Received: May 2, 2006
Results First Received: February 20, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Erosive Esophagitis

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014