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 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.

Study Overview

• Status: Completed
• Conditions: Esophagitis; Reflux
• Intervention / Treatment: Drug: Lansoprazole; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lansoprazole IV 30 mg QD	Drug: Lansoprazole; Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.; Drug: Lansoprazole; Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.; Other Names: AG-1749
Active Comparator: Lansoprazole Capsule 30 mg QD	Drug: Lansoprazole; Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.; Drug: Lansoprazole; Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.; Other Names: AG-1749

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Day 7 vs Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Day 7 vs Day 15
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.	Day 7 vs Day 8
Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole.	Day 8 vs Day 15

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): July 21, 2010
• Last Update Submitted That Met QC Criteria: July 20, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: reflux; Esophagitis; Intravenous; Lansoprazole; gastric acid secretion
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: C02-039; U1111-1114-2148 (Registry Identifier: WHO)