Study of Dexlansoprazole vs Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00321737

Purpose

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

Condition	Intervention	Phase
Esophagitis, Reflux Esophagitis, Peptic	Drug: Dexlansoprazole Drug: Placebo	Phase III

Drug Information available for: Dexlansoprazole Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

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. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean percentage of days without daytime or nighttime heartburn as assessed by daily electronic diary. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Mean percentage of days without nighttime heartburn as assessed by daily electronic diary. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

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
1: Experimental	Drug: Dexlansoprazole Dexlansoprazole 30 mg, capsules, orally, once daily for up to six months.
2: Experimental	Drug: Dexlansoprazole Dexlansoprazole 60 mg, orally, once daily for up to six months.
3: Placebo Comparator	Drug: Placebo Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.

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

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 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.

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

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	T-EE05-135, EUDRA CT # 2006-000419-90
Study First Received:	May 2, 2006
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00321737
Health Authority:	United States: Food and Drug Administration

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

Erosive Esophagitis

Study placed in the following topic categories:

Esophagitis
Esophagitis, Peptic
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases

Ulcer
Benzocaine
Esophageal Diseases
Gastroenteritis
Peptic Ulcer

ClinicalTrials.gov processed this record on January 16, 2009