Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain 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).

Study Overview

• Status: Completed
• Conditions: Esophagitis, Peptic; Esophagitis, Reflux
• Intervention / Treatment: Drug: Dexlansoprazole MR; Drug: Dexlansoprazole MR; Drug: Placebo

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: Interventional
• Enrollment (Actual): 451
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States
    • Hueytown, Alabama, United States
    • Huntsville, Alabama, United States
    • Tallassee, Alabama, United States
    • Tuscaloosa, Alabama, United States
  • Arizona
    • Tucson, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
    • North Little Rock, Arkansas, United States
  • California
    • Azusa, California, United States
    • Carmichael, California, United States
    • Cypress, California, United States
    • Fresno, California, United States
    • Los Angeles, California, United States
    • Modesto, California, United States
    • Newport Beach, California, United States
    • Oakland, California, United States
    • Orange, California, United States
    • San Diego, California, United States
    • Santa Maria, California, United States
  • Colorado
    • Littleton, Colorado, United States
    • Longmont, Colorado, United States
    • Wheat Ridge, Colorado, United States
  • Connecticut
    • Bristol, Connecticut, United States
  • Delaware
    • Newark, Delaware, United States
  • Florida
    • Fort Myers, Florida, United States
    • Miami, Florida, United States
    • Naples, Florida, United States
    • New Smyrna Beach, Florida, United States
    • Ocala, Florida, United States
    • Pembroke Pines, Florida, United States
    • Port Orange, Florida, United States
    • Saint Petersburg, Florida, United States
    • Sarasota, Florida, United States
    • Zephyrhills, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Champaign, Illinois, United States
    • Moline, Illinois, United States
    • North Chicago, Illinois, United States
    • Oak Forest, Illinois, United States
    • Springfield, Illinois, United States
  • Indiana
    • Evansville, Indiana, United States
    • Indianapolis, Indiana, United States
    • Newburgh, Indiana, United States
  • Iowa
    • Davenport, Iowa, United States
  • Kansas
    • Kansas City, Kansas, United States
    • Wichita, Kansas, United States
  • Kentucky
    • Lexington, Kentucky, United States
    • Louisville, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
  • Maryland
    • Chevy Chase, Maryland, United States
    • Prince Frederick, Maryland, United States
  • Mississippi
    • Jackson, Mississippi, United States
  • Missouri
    • Jefferson City, Missouri, United States
    • Kansas City, Missouri, United States
    • Saint Louis, Missouri, United States
  • Montana
    • Missoula, Montana, United States
  • New Jersey
    • Egg Harbor Township, New Jersey, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
    • Charlotte, North Carolina, United States
    • Greensboro, North Carolina, United States
    • High Point, North Carolina, United States
    • Raleigh, North Carolina, United States
    • Wilmington, North Carolina, United States
    • Winston Salem, North Carolina, United States
  • North Dakota
    • Bismarck, North Dakota, United States
  • Ohio
    • Akron, Ohio, United States
    • Columbus, Ohio, United States
    • Dayton, Ohio, United States
    • Mogadore, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
  • Oregon
    • Medford, Oregon, United States
    • Portland, Oregon, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
  • Rhode Island
    • Warwick, Rhode Island, United States
  • South Carolina
    • Anderson, South Carolina, United States
    • Mt. Pleasant, South Carolina, United States
  • South Dakota
    • Sioux Falls, South Dakota, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
    • Germantown, Tennessee, United States
    • Jackson, Tennessee, United States
    • Johnson City, Tennessee, United States
    • Kingsport, Tennessee, United States
  • Texas
    • Amarillo, Texas, United States
    • Conroe, Texas, United States
    • Dallas, Texas, United States
    • Fort Worth, Texas, United States
    • Houston, Texas, United States
    • Odessa, Texas, United States
    • Pharr, Texas, United States
    • Seguin, Texas, United States
    • Temple, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States
    • Norfolk, Virginia, United States
    • Richmond, Virginia, United States
  • Washington
    • Bellevue, Washington, United States
    • Lakewood, Washington, United States
    • Tacoma, Washington, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Experimental: Dexlansoprazole MR 60 mg QD	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
Experimental: Dexlansoprazole MR 90 mg QD	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.	Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.	6 months
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.	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.	6 months
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.	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	6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.	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.	6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.	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.	6 months

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: November 15, 2005
• First Submitted That Met QC Criteria: November 15, 2005
• First Posted (Estimate): November 17, 2005

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Erosive Esophagitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Esophagitis, Peptic; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: T-EE04-087; U1111-1114-1767 (Registry Identifier: WHO)