|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Ception Therapeutics |
|---|---|
| Information provided by (Responsible Party): | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years |
| Enrollment: | 226 |
| Study Start Date: | February 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Reslizumab 1 mg/kg
|
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
|
|
Experimental: 2
Reslizumab 2 mg/kg
|
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
|
|
Experimental: 3
Reslizumab 3 mg/kg
|
Biological: Reslizumab
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4
|
|
Placebo Comparator: 4
Saline
|
Other: Saline
IV (in the vein) on Day 0 of each 28 days cycle (+/-7 days) Number of Cycles=4)
|
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
Show 37 Study Locations| Study Director: | Sponsor's Medical Expert, MD | Cephalon (Ception) |
More Information
| Responsible Party: | Ception Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00538434 History of Changes |
| Other Study ID Numbers: | Res-05-0002 |
| Study First Received: | October 1, 2007 |
| Last Updated: | October 21, 2011 |
| Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee; United States: Food and Drug Administration; United States: Institutional Review Board |
|
Eosinophilic Esophagitis GERD EE Reslizumab |
IL-5 Interleukin-5 Cinquil |
|
Esophagitis Eosinophilic Esophagitis Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis |
Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |