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:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00471094
First received: May 7, 2007
Last updated: January 31, 2012
Last verified: January 2012
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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 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 |
|---|---|
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471094
Show 94 Study Locations
Show 94 Study LocationsSponsors 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. |
| 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 Global Research & Development Center, Inc.:
|
heartburn erosive esophagitis healing population pharmacokinetics Quality of Life (QoL) |
Additional relevant MeSH terms:
|
Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Lansoprazole Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013