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| Sponsored by: |
Ception Therapeutics |
| Information provided by: | Ception Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00538434 |
Purpose
This trial will study three doses of reslizumab versus placebo in children with Eosinophilic Esophagitis (EE). The objectives of the trial will be to study the effectiveness of reslizumab in improving the clinical signs and symptoms and reducing esophageal eosinophils as well as assessing the safety profile compared to placebo.
| Condition | Intervention | Phase |
|
Eosinophilic Esophagitis |
Biological: Reslizumab Other: Saline |
Phase II Phase III |
| MedlinePlus related topics: | Esophagus Disorders |
| ChemIDplus related topics: | Sodium chloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years |
| Estimated Enrollment: | 172 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Reslizumab 1 mg/kg
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Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
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2: Experimental
Reslizumab 2 mg/kg
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Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
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3: Experimental
Reslizumab 3 mg/kg
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Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
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4: Placebo Comparator
Saline
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Other: Saline
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4)
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Eligibility
| Ages Eligible for Study: | 5 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carol M Ward | 215-907-1330 ext 1091 | carol.ward@premier-research.com |
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Show 27 Study Locations |
| Ception Therapeutics |
| Study Director: | H. Jeffery Wilkins, M.D. | Ception Therapeutics, Inc. |
More Information
| Responsible Party: | Ception Therapeutics ( H. Jeffrey Wilkins, M.D./ Senior Vice-President of Clinical Development ) |
| Study ID Numbers: | Res-05-0002 |
| First Received: | October 1, 2007 |
| Last Updated: | June 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00538434 |
| Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee; United States: Food and Drug Administration; United States: Institutional Review Board |
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