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Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis

Primary Purpose

Esophagitis, Reflux

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lansoprazole
Lansoprazole
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagitis focused on measuring Intravenous, gastric acid secretion, Lansoprazole, Esophagitis, reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects were required to have Grade 2, 3 or 4 esophageal findings according to the TAP Grading Scale during the pretreatment endoscopy. Subjects must discontinue histamine H2-receptor antagonists, proton pump ® inhibitors, prokinetic agents, antacids and Carafate before the first dose of drug and during the study. Exclusion Criteria: Gastric or duodenal ulcer (a lesion with appreciable depth ≥3 mm) or a hiatal hernia >5 cm. Subjects could not have a diagnosis of Barrett's esophagus (with or without dysplastic changes). Co-existing systemic disease affecting the esophagus, (ie, scleroderma, viral or fungal infection), radiation therapy to the region of the esophagus, or caustic or physiochemical trauma to the esophagus. Current esophageal stricture requiring dilatation. The endoscope had to pass freely into the stomach during endoscopy. Any strictures could not have been dilated within 12 weeks before beginning the Pretreatment Period. Positive H pylori by rapid urease test (CLO® test Kimberly-Clark Corporation). Uncontrolled, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, gastrointestinal, neurological or endocrine disease or other abnormality (other than the erosive esophagitis disease being studied). Diagnosis of Zollinger-Ellison syndrome, esophageal varices, symptomatic pancreaticobiliary tract disease, cholecystitis, rheumatoid arthritis, lupus, or malignancy (except basal cell carcinoma).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Lansoprazole IV 30 mg QD

    Lansoprazole Capsule 30 mg QD

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maximal Acid Output obtained 22 hours after the last dose of IV lansoprazole compared to the Maximal Acid Output obtained 22 hours after the last dose of oral lansoprazole following pentagastrin stimulation in both instances.

    Secondary Outcome Measures

    Basal Acid Output obtained 21 hours after the last dose of IV lansoprazole compared with that obtained 21 hours after the last dose of oral lansoprazole.
    Maximum Acid Output and Basal Acid Output measurements obtained 21 hours and 22 hours, respectively, after the first dose of IV lansoprazole versus those obtained after the last dose of oral lansoprazole.
    Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole.

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    July 20, 2010
    Sponsor
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00175045
    Brief Title
    Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis
    Official Title
    A Phase 2, Open-Label Multicenter Study to Evaluate the Pharmacodynamics of Intravenous Lansoprazole to That of Oral Lansoprazole in Subjects With Erosive Esophagitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    October 2003 (Actual)
    Study Completion Date
    October 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Takeda

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.
    Detailed Description
    Phase 2, open label, multi-center, 2-period study to compare the pharmacodynamics of IV lansoprazole 30 mg to oral lansoprazole 30 mg in subjects with erosive esophagitis (grade >or= 2)diagnosed by endoscopy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophagitis, Reflux
    Keywords
    Intravenous, gastric acid secretion, Lansoprazole, Esophagitis, reflux

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lansoprazole IV 30 mg QD
    Arm Type
    Experimental
    Arm Title
    Lansoprazole Capsule 30 mg QD
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Lansoprazole
    Intervention Description
    Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Lansoprazole
    Other Intervention Name(s)
    AG-1749
    Intervention Description
    Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.
    Primary Outcome Measure Information:
    Title
    Maximal Acid Output obtained 22 hours after the last dose of IV lansoprazole compared to the Maximal Acid Output obtained 22 hours after the last dose of oral lansoprazole following pentagastrin stimulation in both instances.
    Time Frame
    Day 7 vs Day 15
    Secondary Outcome Measure Information:
    Title
    Basal Acid Output obtained 21 hours after the last dose of IV lansoprazole compared with that obtained 21 hours after the last dose of oral lansoprazole.
    Time Frame
    Day 7 vs Day 15
    Title
    Maximum Acid Output and Basal Acid Output measurements obtained 21 hours and 22 hours, respectively, after the first dose of IV lansoprazole versus those obtained after the last dose of oral lansoprazole.
    Time Frame
    Day 7 vs Day 8
    Title
    Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole.
    Time Frame
    Day 8 vs Day 15

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects were required to have Grade 2, 3 or 4 esophageal findings according to the TAP Grading Scale during the pretreatment endoscopy. Subjects must discontinue histamine H2-receptor antagonists, proton pump ® inhibitors, prokinetic agents, antacids and Carafate before the first dose of drug and during the study. Exclusion Criteria: Gastric or duodenal ulcer (a lesion with appreciable depth ≥3 mm) or a hiatal hernia >5 cm. Subjects could not have a diagnosis of Barrett's esophagus (with or without dysplastic changes). Co-existing systemic disease affecting the esophagus, (ie, scleroderma, viral or fungal infection), radiation therapy to the region of the esophagus, or caustic or physiochemical trauma to the esophagus. Current esophageal stricture requiring dilatation. The endoscope had to pass freely into the stomach during endoscopy. Any strictures could not have been dilated within 12 weeks before beginning the Pretreatment Period. Positive H pylori by rapid urease test (CLO® test Kimberly-Clark Corporation). Uncontrolled, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, gastrointestinal, neurological or endocrine disease or other abnormality (other than the erosive esophagitis disease being studied). Diagnosis of Zollinger-Ellison syndrome, esophageal varices, symptomatic pancreaticobiliary tract disease, cholecystitis, rheumatoid arthritis, lupus, or malignancy (except basal cell carcinoma).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis

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