| September 12, 2005 |
| December 4, 2008 |
| June 2003 |
| October 2003 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| A comparison of intravenous vs oral lansoprazole on gastric acid output |
| Complete list of historical versions of study NCT00175045 on ClinicalTrials.gov Archive Site |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
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- Basal Acid Output (BAO) [ Time Frame: Day 7 vs Day 15 ]
- Maximum Acid Output (MAO) and Basal Acid Output (BAO) [ Time Frame: Day 7 vs Day 8 ]
- Maximum Acid Output (MAO) and Basal Acid Output (BAO) [ Time Frame: Day 8 vs Day 15 ]
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| Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis |
| A Phase 2, Open-Label Multicenter Study to Evaluate the Pharmacodynamics of Intravenous Lansoprazole to That of Oral Lansoprazole in Subjects With Erosive Esophagitis |
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. |
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. |
| Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study |
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| Drug: Lansoprazole |
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| Completed |
| 68 |
| October 2003 |
| October 2003 (final data collection date for primary outcome measure) |
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).
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00175045 |
| Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc. |
| C02-039 |
| Takeda Global Research & Development Center, Inc. |
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| Study Director: |
Medical Director |
Takeda Global Research & Development Center, Inc. |
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| Takeda Global Research & Development Center, Inc. |
| December 2008 |