Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis

Esophagitis Clinical Trial

Official title:

A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471094
• Other study ID #: Z-EE05-123
• Secondary ID: U1111-1127-6202
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2007
• Last updated: January 31, 2012
• Start date: May 2007
• Est. completion date: October 2007

Study information

• Verified date: January 2012
• 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 is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Description:

This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 831
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion Criteria:

• Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condition likely to require surgery; cancer within 5 years of screening; or abnormal laboratory values.

• Co-existing diseases affecting the esophagus; history of esophageal radiation therapy, cryotherapy, or physiochemical trauma.

• History of esophageal surgery or dilatation of an esophageal stricture other than Schatzki's ring; gastric or duodenal surgery except simple oversew of an ulcer.

• Active gastric or duodenal ulcers or acute upper gastrointestinal hemorrhage within 30 days prior to screening.

• Current or history of Zollinger-Ellison syndrome or other hypersecretory conditions.

• Allergy to any proton pump inhibitor drug (omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole), any component of Ilaprazole, or antacid.

• Unable to tolerate lactose.

• Use of the following medications prior to randomization or anticipated use during the study: proton pump inhibitors, antacids, biphosphonates, histamine (H2) receptor antagonist (examples: Zantac, Tagamet), sucralfate, misoprostol, corticosteroids, prokinetics, Non-steroidal anti-inflammatory drugs (NSAIDs), strong anticholinergics, anticoagulant/anti-platelet aggregate therapy, anticoagulants, digoxin, theophylline, phenytoin.

• History of alcoholism or drug addiction.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis

Intervention

Drug:
• Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
• Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
• Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
• Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.		Week 4	No
Secondary	The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.		Week 8	No