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

NCT ID: NCT00175045

Last Updated: 2010-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2003-10-31

Brief Summary

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.

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.

Conditions

Esophagitis; Reflux

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lansoprazole IV 30 mg QD

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.

Lansoprazole Capsule 30 mg QD

Group Type: ACTIVE_COMPARATOR

Lansoprazole

Intervention Type: DRUG

Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.

Interventions

Lansoprazole

Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.

Intervention Type: DRUG

Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.

Intervention Type: DRUG

Other Intervention Names

AG-1749

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Global Research & Development Center, Inc.

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

U1111-1114-2148

Identifier Type: REGISTRY

Identifier Source: secondary_id

C02-039

Identifier Type: -

Identifier Source: org_study_id