Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00255190

Purpose

The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: Dexlansoprazole MR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)

Resource links provided by NLM:

MedlinePlus related topics: GERD Heartburn

Drug Information available for: Dexlansoprazole

U.S. FDA Resources

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

Primary Outcome Measures:

Mean Change From Baseline to Month 12 for Hemoglobin Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Hematocrit Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Platelet Count Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for White Blood Cell Count Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Creatinine Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Calcium Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Total Bilirubin Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Serum Gastrin Levels [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Systolic Blood Pressure [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Mean Change From Baseline to Month 12 for Pulse Rate [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: Yes ]
Changes From Baseline to Final Visit in Antrum Biopsy Results [ Time Frame: Baseline and Final Visit (up to 12 months) ] [ Designated as safety issue: Yes ]
Changes From Baseline to Final Visit in Fundus Biopsy Results [ Time Frame: Baseline and Final Visit (up to 12 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mean Change From Baseline to Month 1 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 1 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 1 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 9 ] [ Designated as safety issue: No ]
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]

Enrollment:	591
Study Start Date:	January 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Dexlansoprazole MR Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
2: Experimental	Drug: Dexlansoprazole MR Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.

Detailed Description:

This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions.

Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study.

After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months.

Approximately 200 study sites in the U.S. will participate.

For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.

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 either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

Any condition that may require inpatient surgery during the course of the study.
Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
Use of antacids [except for study supplied Gelusil®].
Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
Evidence of uncontrolled systemic disease.
Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
Need to take blood thinners.
Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
Has had radiation or cryotherapy to the esophagus.
Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
History of alcohol abuse.
Has acquired immunodeficiency syndrome.
Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
Received a blood product transfusion within 3 months of taking the first dose of study drug.
Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255190

Show 181 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

Kapidex Package Insert This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers:	T-GI04-088
Study First Received:	November 15, 2005
Results First Received:	June 24, 2009
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00255190 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Gastroesophageal Reflux Disease

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Anti-Infective Agents
Pyrosis
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Heartburn
Quality of Life
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on September 02, 2009