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

Esophagitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175045
• Other study ID #: C02-039
• Secondary ID: U1111-1114-2148
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 20, 2010
• Start date: June 2003
• Est. completion date: October 2003

Study information

• Verified date: July 2010
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis
• Reflux

Intervention

Drug:
• Lansoprazole
Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days.
• Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole.		Day 8 vs Day 15	No

External Links

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