We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00321737
First Posted: May 4, 2006
Last Update Posted: February 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]
    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.


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( EudraCT Number )
U1111-1113-9433 ( Registry Identifier: WHO )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: February 20, 2009
Results First Posted: August 28, 2009
Last Update Posted: February 3, 2012
Last Verified: February 2012

Keywords provided by Takeda:
Erosive Esophagitis

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