Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Dexlansoprazole MR

• Registration Number: NCT00255190
• Lead Sponsor: Takeda

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Study Start: 2006-01
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-06-24
• Results First Submitted QC: 2009-06-24
• Results First Posted: 2009-08-12
• Status Verified: 2011-04
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 591

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexlansoprazole MR 90 mg QD	Dexlansoprazole MR	-
Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Platelet Count Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for White Blood Cell Count Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Hemoglobin Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Hematocrit Values	Baseline and Month 12	Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Mean Change From Baseline to Month 12 for Creatinine Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Calcium Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Total Bilirubin Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values	Baseline and Month 12
Mean Change From Baseline to Month 12 for Serum Gastrin Levels	Baseline and Month 12
Mean Change From Baseline to Month 12 for Systolic Blood Pressure	Baseline and Month 12
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure	Baseline and Month 12
Mean Change From Baseline to Month 12 for Pulse Rate	Baseline and Month 12
Changes From Baseline to Final Visit in Antrum Biopsy Results	Baseline and Final Visit (up to 12 months)	Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Changes From Baseline to Final Visit in Fundus Biopsy Results	Baseline and Final Visit (up to 12 months)	Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score	Baseline and Month 6	Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score	Baseline and Month 9	Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score	Baseline and Month 12	Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 1 for PAGI-QOL Total Score	Baseline and Month 1	Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score	Baseline and Month 3	Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score	Baseline and Month 6	Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score	Baseline and Month 9	Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score	Baseline and Month 12	Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score	Baseline and Month 1	Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score	Baseline and Month 3	Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).