Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT00272818 - Study to Identify Non-Invasive Markers of Gastrointestinal Allergy
Recruiting NCT05326113 - The Effect of Physiotherapy on Post POEM Reflux N/A
Recruiting NCT01696734 - Domperidone in Treating Patients With Gastrointestinal Disorders Phase 3
Terminated NCT02575391 - The Effects of Whole Food Intervention on Mucositis in Patients Treated for Thoracic Cancer Phase 1/Phase 2
Completed NCT00256529 - Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia N/A
Completed NCT00123630 - A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab Phase 2
Completed NCT00081315 - Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer Phase 2
Completed NCT00579410 - Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule N/A
Recruiting NCT05109819 - Esophagus-sparing Radiotherapy for Metastatic Spinal Cord Compression. N/A
Withdrawn NCT01824199 - CYP2C19 Genotype Predictor of Gastric Acid Suppression Early Phase 1
Completed NCT01556919 - Esophageal Monitoring Device for Assessing Mucosal Impedance
Active, not recruiting NCT03835663 - The Bacterial Composition of the Stomach in Reflux Disease
Completed NCT00195208 - Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis Phase 3
Completed NCT00175045 - Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis Phase 2
Completed NCT05129670 - Clinical Investigation to Assess the Acid Neutralisation Activity of a Calcite Chewing Gum N/A
Recruiting NCT05004155 - Twenty Four Hour Ambulatory pH & Impedance Testing: Normative Data for Indian Population
Completed NCT03228147 - Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment N/A
Completed NCT00133770 - Intravenous (IV) Pantoprazole in Erosive Esophagitis Phase 4
Completed NCT01322633 - Risk of Cancer Among Pantoprazole Users N/A