Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis - Full Text View

Purpose

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).

Condition	Intervention	Phase
Esophagitis, Reflux Esophagitis, Peptic	Drug: Dexlansoprazole MR Drug: Placebo	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Drug Information available for: Lansoprazole Dexlansoprazole

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 Outcome Measures:

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.

Enrollment:	445
Study Start Date:	May 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dexlansoprazole MR 30 mg QD	Drug: Dexlansoprazole MR Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to six months. Other Names: TAK-390MR Kapidex Dexilant
Experimental: Dexlansoprazole MR 60 mg QD	Drug: Dexlansoprazole MR Dexlansoprazole MR 60 mg, orally, once daily for up to six months. Other Names: TAK-390MR Kapidex Dexilant
Placebo Comparator: Placebo	Drug: Placebo Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321737

Show 98 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

For the Dexilant package insert refer to this link This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to this link This link exits the ClinicalTrials.gov site

Publications:

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 oesophagitis. Aliment Pharmacol Ther. 2009 Apr 1;29(7):742-54. Epub 2009 Feb 7.

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. Epub 2009 Sep 4.

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. Epub 2010 Feb 27.

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. Epub 2010 Nov 24.

Responsible Party:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00321737 History of Changes
Other Study ID Numbers:	T-EE05-135, 2006-000419-90, U1111-1113-9433
Study First Received:	May 2, 2006
Results First Received:	February 20, 2009
Last Updated:	February 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Erosive Esophagitis

Additional relevant MeSH terms:

Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Lansoprazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013