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Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
This study has been completed.
First Received: May 7, 2007   Last Updated: December 8, 2008   History of Changes
Sponsored by: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00471094
  Purpose

This is a study to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg) compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.


Condition Intervention Phase
Esophagitis
Drug: Ilaprazole
Drug: Lansoprazole
Phase II

MedlinePlus related topics: Endoscopy
Drug Information available for: Lansoprazole Ilaprazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 831
Study Start Date: May 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
2: Experimental Drug: Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
3: Experimental Drug: Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
4: Active Comparator Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471094

  Show 94 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Director: Medical Director Takeda Global Research & Development Center, Inc.
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Sciences )
Study ID Numbers: Z-EE05-123
Study First Received: May 7, 2007
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00471094     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
heartburn
erosive esophagitis
healing
population pharmacokinetics
Quality of Life (QoL)

Study placed in the following topic categories:
Esophagitis
Pyrosis
Digestive System Diseases
Esophageal Disorder
Gastrointestinal Diseases
Heartburn
Quality of Life
Lansoprazole
Esophageal Diseases
Gastroenteritis

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions
Esophagitis
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009