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CompletedNCT00255151Updated Feb 3, 2012Results posted

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

A Phase 3 interventional study of Dexlansoprazole MR and Dexlansoprazole MR in Esophagitis, Reflux and Esophagitis, Peptic, sponsored by Takeda. Completed at 100 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-03.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
451
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Esophagitis, Reflux
  • Esophagitis, Peptic

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Keywords

  • Erosive Esophagitis
03

In context

Esophagitis, Peptic

316 studies on the registry are indexed under Esophagitis, Peptic; 33 are open to participants now.

This study's enrollment of 451 is above the median of 96 across 220 interventional studies indexed under Esophagitis, Peptic.

Browse Esophagitis, Peptic studies →

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

Browse Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
451 participants (actual)

Study arms

  • Experimental
    Dexlansoprazole MR 60 mg QD

    Drug: Dexlansoprazole MR

  • Experimental
    Dexlansoprazole MR 90 mg QD

    Drug: Dexlansoprazole MR

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugDexlansoprazole MR

    Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.

    Also known as: TAK-390MR, Dexilant, Kapidex

  • DrugDexlansoprazole MR

    Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.

    Also known as: TAK-390MR, Kapidex, Dexilant

  • DrugPlacebo

    Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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.

    Time frame: 6 months

  4. 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.

    Time frame: 6 months

07

Results

Posted Aug 28, 2009

Participant flow

Subjects were enrolled at 105 sites in the United States; date of first dose (04 January 2006; date of last procedure: 14 November 2006).

Participant flow — Overall Study
MilestonePlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Started140159152
Completed17110103
Not completed1234949
Withdrew: Adverse event1069
Withdrew: Lost to follow-up434
Withdrew: Withdrawal by subject18178
Withdrew: Noncompliance012
Withdrew: Subject request/subject unavailable112
Withdrew: Relapse of erosive esophagitis781612
Withdrew: Possible barrett's esophagus138
Withdrew: Esophageal stricture001
Withdrew: Therapeutic failure1123

Outcome measures

PrimaryPercentage 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.

Time frame:
6 months
Reported as:
Number · Percentage of Subjects
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Percentage of SubjectsPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.14.3 (8.4 to 22.2)66.4 (58.3 to 73.9)64.5 (55.9 to 72.4)
Statistical analysis
  • Placebo QD vs Dexlansoprazole MR 60 mg QD · Fisher Exact · p = <0.00001 (Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.)
  • Placebo QD vs Dexlansoprazole MR 90 mg QD · Fisher Exact · p = <0.00001 (Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.)
  • Dexlansoprazole MR 60 mg QD vs Dexlansoprazole MR 90 mg QD · Fisher Exact · p = 0.80473 (Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.)
SecondaryPercentage 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.

Time frame:
6 months
Reported as:
Median · Percentage of Days
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
Percentage of DaysPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.19.2 ± 29.395.8 ± 30.794.4 ± 30.0
Statistical analysis
  • Placebo QD vs Dexlansoprazole MR 60 mg QD · Wilcoxon (Mann-Whitney) · p = <0.00001 (The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.)
  • Placebo QD vs Dexlansoprazole MR 90 mg QD · Wilcoxon (Mann-Whitney) · p = <0.00001 (The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.)
  • Dexlansoprazole MR 60 mg QD vs Dexlansoprazole MR 90 mg QD · Wilcoxon (Mann-Whitney) · p = 0.76046 (Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.)
SecondaryPercentage 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

Time frame:
6 months
Reported as:
Mean · Percentage of Days
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
Percentage of DaysPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.29.5 ± 29.379.7 ± 30.779.2 ± 30.0
PrimaryPercentage 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.

Time frame:
6 months
Reported as:
Number · Percentage of Subjects
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
Percentage of SubjectsPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method25.786.682.1
Statistical analysis
  • Placebo QD vs Dexlansoprazole MR 60 mg QD · Log Rank · p = <0.00001 (Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.)
  • Placebo QD vs Dexlansoprazole MR 90 mg QD · Log Rank · p = <0.00001 (Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.)
  • Dexlansoprazole MR 60 mg QD vs Dexlansoprazole MR 90 mg QD · Log Rank · p = 0.37161 (Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.)
SecondaryPercentage 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.

Time frame:
6 months
Reported as:
Median · Percentage of Days
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
Percentage of DaysPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.50.0 ± 35.398.3 ± 25.597.1 ± 26.3
Statistical analysis
  • Placebo QD vs Dexlansoprazole MR 60 mg QD · Wilcoxon (Mann-Whitney) · p = <0.00001 (The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.)
  • Placebo QD vs Dexlansoprazole MR 90 mg QD · Wilcoxon (Mann-Whitney) · p = <0.00001 (The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.)
  • Dexlansoprazole MR 60 mg QD vs Dexlansoprazole MR 90 mg QD · Wilcoxon (Mann-Whitney) · p = 0.59700 (Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.)
SecondaryPercentage 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.

Time frame:
6 months
Reported as:
Mean · Percentage of Days
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
Percentage of DaysPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.48.3 ± 35.387.1 ± 25.585.4 ± 26.3

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo QD———
Dexlansoprazole MR 60 mg QD———
Dexlansoprazole MR 90 mg QD———
Most frequent serious events
Most frequent serious events
EventPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Coronary Artery Disorders Not Elsewhere Classified (NEC)Cardiac disorders0/1400/1591/152
Acute and Chronic PancreatitisGastrointestinal disorders0/1400/1591/152
Non-site Specific Injuries NECInjury, poisoning and procedural complications0/1400/1591/152
Musculoskeletal and Connective Tissue Signs and Symptoms NECMusculoskeletal and connective tissue disorders0/1400/1591/152
Breast and Nipple Neoplasms MalignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1400/1591/152
Pain and Discomfort NECGeneral disorders0/1401/1590/152
Uterine Disorders NECReproductive system and breast disorders0/1401/1590/152
Most frequent other events
Most frequent other events
EventPlacebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QD
Diarrhoea (Excluding [Excl] Infective)Gastrointestinal disorders1/14010/15910/152
Gastritis (Excl Infective)Gastrointestinal disorders1/14010/1596/152
Gastrointestinal and Abdominal Pains (Excl Oral and Throat)Gastrointestinal disorders2/14010/1596/152
Flatulence, Bloating and DistensionGastrointestinal disorders0/1408/1593/152
Upper Respiratory Tract InfectionsInfections and infestations5/1404/1597/152

Baseline characteristics

Age Continuous
Age Continuous(years)Placebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QDTotal
Mean48.2 ± 12.8849.7 ± 12.6648.8 ± 13.7648.9 ± 13.09
Age, Customized
Age, Customized(participants)Placebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QDTotal
<45 years485556159
45 to <65 years818681248
≥65 years11181544
Sex: Female, Male
Sex: Female, Male(Participants)Placebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QDTotal
Female707670216
Male708382235
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QDTotal
American Indian or Alaska Native2215
Asian2305
Native Hawaiian or Other Pacific Islander0000
Black or African American11171139
White124135136395
More than one race1247
Unknown or Not Reported0000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QDTotal
Hispanic or Latino15191448
Not Hispanic or Latino125140138403
Unknown or Not Reported0000
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)(participants)Placebo QDDexlansoprazole MR 60 mg QDDexlansoprazole MR 90 mg QDTotal
A: ≥1 mucosal break <5 mm586054172
B: ≥1 mucosal break ≥5 mm486158167
C: ≥1 mucosal break <75% of circumference28333293
D: ≥1 mucosal break ≥75% of circumference65819
08

Study locations

100 sites
  • Anniston, Alabama, United States
  • Hueytown, Alabama, United States
  • Huntsville, Alabama, United States
  • Tallassee, Alabama, United States
  • Tuscaloosa, Alabama, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • North Little Rock, Arkansas, United States
  • 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
  • Littleton, Colorado, United States
  • Longmont, Colorado, United States
  • Wheat Ridge, Colorado, United States
  • Bristol, Connecticut, United States
  • Newark, Delaware, United States
  • 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
  • Sarasota, Florida, United States
  • St. Petersburg, Florida, United States
  • Zephyrhills, Florida, United States
  • Atlanta, Georgia, United States
  • Champaign, Illinois, United States
  • Moline, Illinois, United States
  • North Chicago, Illinois, United States
  • Oak Forest, Illinois, United States
  • Springfield, Illinois, United States
  • Evansville, Indiana, United States
  • Indianapolis, Indiana, United States
  • Newburgh, Indiana, United States
  • Davenport, Iowa, United States
  • Kansas City, Kansas, United States
  • Wichita, Kansas, United States
  • Lexington, Kentucky, United States
  • Louisville, Kentucky, United States
  • Baton Rouge, Louisiana, United States
  • Chevy Chase, Maryland, United States
  • Prince Frederick, Maryland, United States
  • Jackson, Mississippi, United States
  • Jefferson City, Missouri, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Missoula, Montana, United States
  • Egg Harbor, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • 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
  • Bismarck, North Dakota, United States
  • Akron, Ohio, United States
  • Columbus, Ohio, United States
  • Dayton, Ohio, United States
  • Mogadore, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Medford, Oregon, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Warwick, Rhode Island, United States
  • Anderson, South Carolina, United States
  • Mt. Pleasant, South Carolina, United States
  • Sioux Falls, South Dakota, United States
  • Chattanooga, Tennessee, United States
  • Germantown, Tennessee, United States
  • Jackson, Tennessee, United States
  • Johnson City, Tennessee, United States
  • Kingsport, Tennessee, United States
  • 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
  • Salt Lake City, Utah, United States
  • Charlottesville, Virginia, United States
  • Norfolk, Virginia, United States
  • Richmond, Virginia, United States
  • Bellevue, Washington, United States
  • Lakewood, Washington, United States
  • Tacoma, Washington, United States
  • Milwaukee, Wisconsin, United States
09

References and documents

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. PubMed 19681809 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00255151
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Nov 17, 2005
Start date
Jan 2006
Primary completion
Nov 2006
Completion
Nov 2006
Results posted
Aug 28, 2009
Last update
Feb 3, 2012

Study contacts

Medical Director
study chair · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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