Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
This study has been completed.
Study NCT00538434   Information provided by Ception Therapeutics
First Received: October 1, 2007   Last Updated: October 9, 2009   History of Changes

October 1, 2007
October 9, 2009
February 2008
October 2009   (final data collection date for primary outcome measure)
  • esophageal eosinophil counts (co-primary) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • EE Global Assessment (co-primary) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • esophageal eosinophil counts (co-primary) [ Time Frame: 15 weeks ]
  • EE Global Assessment (co-primary) [ Time Frame: 15 weeks ]
Complete list of historical versions of study NCT00538434 on ClinicalTrials.gov Archive Site
  • EE Predominant Symptom Assessment [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • Child Health Questionnaire [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
  • EE Predominant Symptom Assessment [ Time Frame: 15 weeks ]
  • Child Health Questionnaire [ Time Frame: 15 weeks ]
 
Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years
An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years

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.

 
Phase II, Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eosinophilic Esophagitis
  • Biological: Reslizumab
  • Other: Saline
  • Experimental: Reslizumab 1 mg/kg
  • Experimental: Reslizumab 2 mg/kg
  • Experimental: Reslizumab 3 mg/kg
  • Placebo Comparator: Saline
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
226
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • written informed consent obtained
  • male or female patients aged 5 to 18 years at time of screening
  • of non-childbearing potential, of childbearing potential and willing to use specific barrier methods outlined in the protocol
  • confirmed active eosinophilic esophagitis (at Screening or within six weeks prior to Baseline Visit) as defined by esophageal mucosal eosinophils greater than or equal to 24 per hpf (400X magnification)
  • within the week prior to dosing, patient has one of the following symptoms of moderate (or worse) severity: vomiting, regurgitation (acid taste or feeling material movement upward, abdominal, chest pain/heartburn (burning or pain behind the sternum), or difficulty swallowing
  • been on a therapeutic dose of PPIs (with or without histamine H2 receptor antagonists)for at least four weeks without resolution of symptoms, or by negative pH probe (with or without having failed a course of PPIs)

Exclusion Criteria:

  • another disorder that causes esophageal eosinophilia (e.g.,HES,Churg Strauss vasculitis, EG, or a parasitic infection)
  • history of abnormal gastric or duodenal biopsy or documented GI disorders (e.g.,Celiac Disease, Crohn's disease or Helicobacter pylori infection)
  • history of the following GI surgeries:fundoplication, gastric surgery or surgery for intestinal atresia -use of systemic immunosuppressive or immunomodulating agents (anti- immunoglobulin E [IgE] mAb, methotrexate, cyclosporin, interferon α, or anti tumor necrosis factor [TNF] mAb) within six months prior to study entry.
  • received attenuated live attenuated vaccines (e.g., measles, mumps, rubella [MMR], Bacille Calmette Guerin [BCG],varicella, Flumist or polio) within three months prior to study entry.
  • use of swallowed inhaled corticosteroids for the treatment of EE within one month prior to study entry. Note: Inhaled and nasal corticosteroids for the treatment of asthma and allergies, respectively, are permitted provided that the dose remains the same during the study
  • a stricture on endoscopy that prevents passage of the endoscope
  • participation in any investigational drug or device study within 30 days prior to study entry.
  • female subjects who are pregnant or nursing.
  • concurrent infection or disease that may preclude assessment of eosinophilic esophagitis.
  • concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency).
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00538434
H. Jeffrey Wilkins, M.D./ Senior Vice-President of Clinical Development, Ception Therapeutics
Res-05-0002
Ception Therapeutics
 
Study Director: H. Jeffery Wilkins, M.D. Ception Therapeutics, Inc.
Ception Therapeutics
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP