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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00175045 |
The objective of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole 30 mg to oral lansoprazole 30 mg capsules in subjects with erosive esophagitis.
Condition | Intervention | Phase |
---|---|---|
Esophagitis Reflux |
Drug: Lansoprazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study |
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 |
Enrollment: | 68 |
Study Start Date: | June 2003 |
Study Completion Date: | October 2003 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Lansoprazole
Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
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2: Active Comparator |
Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences ) |
Study ID Numbers: | C02-039 |
Study First Received: | September 12, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00175045 |
Health Authority: | United States: Food and Drug Administration |
Intravenous gastric acid secretion Lansoprazole Esophagitis reflux |
Esophagitis Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Lansoprazole Esophageal Diseases Gastroenteritis |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |