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

Condition(s) targeted: Esophagitis; Reflux

Intervention: Lansoprazole (Drug); Lansoprazole (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: TAP Pharmaceutical Products Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.

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.

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

Primary outcome: 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:

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.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

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

Starting date: June 2003
Ending date: October 2003
Last updated: June 13, 2008