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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacodynamics Study

Study Primary Completion Date: October 2003

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.

Intervention(s) in this Clinical Trial

• Drug: Lansoprazole
  • 30 mg IV once daily for 7 days
• Drug: Lansoprazole
  • 30 mg orally once daily for 7 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lansoprazole IV
• Active Comparator: 2
  • Lansoprazole

Primary 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.
  • Time Frame: Day 7 vs Day 15
    Safety Issue?: No

Secondary 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.
  • Time Frame: Day 7 vs Day 15
    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
    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
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00175045

Study ID Number: C02-039

ClinicalTrials.gov Identifier: NCT00175045

Health Authority: United States: Food and Drug Administration

Trial results can be found on this link

For FDA Safety Alerts and Recalls refer to this link

For the Prevacid Package Insert refer to this link