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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00471094 |
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 |
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Esophagitis |
Drug: Ilaprazole Drug: Lansoprazole |
Phase II |
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. |
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 |
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1: Experimental |
Drug: Ilaprazole
Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
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2: Experimental |
Drug: Ilaprazole
Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
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3: Experimental |
Drug: Ilaprazole
Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
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4: Active Comparator |
Drug: Lansoprazole
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Director | Takeda Global Research & Development Center, Inc. |
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 |
Health Authority: | United States: Food and Drug Administration |
heartburn erosive esophagitis healing population pharmacokinetics Quality of Life (QoL) |
Esophagitis Pyrosis Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Heartburn Quality of Life Lansoprazole Esophageal Diseases Gastroenteritis |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |