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.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00471094
First received: May 7, 2007
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Esophagitis
Drug: Ilaprazole
Drug: Lansoprazole
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Takeda:

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
Experimental: Ilaprazole 5 mg QD Drug: Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 20 mg QD Drug: Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 40 mg QD Drug: Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
Active Comparator: Lansoprazole 30 mg QD 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471094

  Show 94 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00471094     History of Changes
Other Study ID Numbers: Z-EE05-123, U1111-1127-6202
Study First Received: May 7, 2007
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
heartburn
erosive esophagitis
healing
population pharmacokinetics
Quality of Life (QoL)

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

ClinicalTrials.gov processed this record on August 27, 2014