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Completed

NCT Number: NCT00321737

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining 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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

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Key information

Conditions

Esophagitis, Reflux Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kippa-Ring, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexlansoprazole MR

Drug

Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months.

Other names: TAK-390MR, Kapidex, Dexilant

Placebo

Drug

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

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 4, 2006
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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