|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Takeda Global Research & Development Center, Inc. |
|---|---|
| Information provided by (Responsible Party): | Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00471094 |
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. |
| 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 94 Study Locations| Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
More Information
| 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 |
|
heartburn erosive esophagitis healing population pharmacokinetics Quality of Life (QoL) |
|
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 |