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

Esophagitis, Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255164
• Other study ID #: T-EE04-086
• Secondary ID: U1111-1114-1355
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: February 1, 2012
• Start date: January 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 (this study, NCT00255164) and T-EE04-087 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Esophagitis, Reflux

Intervention

Drug:
• Dexlansoprazole MR
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
• Dexlansoprazole MR
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
• Placebo
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View Citation

Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21 — View Citation

Wyrwich KW, Mody R, Larsen LM, Lee M, Harnam N, Revicki DA. Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants. Qual Life Res. 2010 May;19(4):551-64. doi: 10.1007/s11136-010-9620-x. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   For FDA Safety Alerts and Recalls refer to this link
•   For the Dexilant package insert refer to this link