Study of Dexlansoprazole vs Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis.

A 6-month study to assess the ability of daily treatment with dexlansoprazole 30mg, 60 mg or placebo in maintaining healing of erosive esophagitis.

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.

Conditions

Peptic or Reflux Esophagitis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. [Time Frame: Month 6]

Secondary Outcome Measures:

• Mean percentage of days without daytime or nighttime heartburn as assessed by daily electronic diary. [Time Frame: Month 6]
• Mean percentage of days without nighttime heartburn as assessed by daily electronic diary. [Time Frame: Month 6]

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 (30 mg and 60 mg) with that of placebo, in maintaining healing of erosive esophagitis

Study Start

May 2006; Study completion: May 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Subjects must have successfully completed the Phase 3 Study T-EE04-084 or T-EE04-085; and have healed esophageal erosions proven by endoscopy.

Exclusion Criteria:

• Use of prescription or non-prescription 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 NSAIDs or COX 2 inhibitors.
• Need for continuous anticoagulant therapy.
• Evidence of uncontrolled systemic disease.
• Subjects who have participated in either maintenance study (T-EE04-086 or T-EE04-087).
• Subjects who, in the opinion of the investigator, is unable to comply with the requirements of the study or is unsuitable for any reason.

Total Enrolment

445

Contact Details

Australian Locations:

• Kippa Ring, Australia

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