Clinical trial NCT00471094: Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophagitis
Keywords: heartburn
erosive esophagitis
healing
population pharmacokinetics
Quality of Life (QoL)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 831
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy.
timeFrame: Week 4
Secondary outcomes:
measure: The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy.
timeFrame: Week 8
Other outcomes:
Locations:
city: Hueytown
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Sherwood
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Cypress
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Irvine
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Mission Hills
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: West Covina
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Longmont
country: United States
state: Colorado
city: Pueblo
country: United States
state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Longwood
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Tucker
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Moline
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Clive
country: United States
state: Iowa
city: Davenport
country: United States
state: Iowa
city: Dubuque
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: Chevy Chase
country: United States
state: Maryland
city: Prince Frederick
country: United States
state: Maryland
city: Olive Branch
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Mexico
country: United States
state: Missouri
city: Egg Harbor Township
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Beaver Falls
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Goose Creek
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Midvale
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Newport News
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Monroe
country: United States
state: Wisconsin
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: