Efficacy and Safety of Dexlansoprazole MR Compared to Placebo 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 TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321737
• Other study ID #: T-EE05-135
• Secondary ID: 2006-000419-90U1
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2006
• Last updated: February 1, 2012
• Start date: May 2006
• Est. completion date: May 2007

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) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• 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 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.

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

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  Estonia,  Latvia,  Lithuania,  Slovakia, 

References & Publications (4)

Friedlander EA, Pallentino J, Miller SK, VanBeuge SS. The evolution of proton pump inhibitors for the treatment of gastroesophageal reflux disease. J Am Acad Nurse Pract. 2010 Dec;22(12):674-83. doi: 10.1111/j.1745-7599.2010.00578.x. Epub 2010 Nov 24. Rev — View Citation

Metz DC, Howden CW, Perez MC, Larsen L, O'Neil J, Atkinson SN. Clinical trial: dexlansoprazole MR, a proton pump inhibitor with dual delayed-release technology, effectively controls symptoms and prevents relapse in patients with healed erosive oesophagiti — 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