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A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314938
First Posted: April 17, 2006
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling

Condition Intervention Phase
Growth Hormone Deficiency Drug: PHA-794428 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PK, IGF-1 and safety measurements up to 2 weeks after dosing

Secondary Outcome Measures:
  • Antibody and IGFBP-3 measurements

Estimated Enrollment: 32
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:
The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Male and female children with a minimum age of 6 years
  • 2. Prepubertal as defined by Tanner staging
  • 3. Growth hormone deficiency

Exclusion Criteria:

  • 1. PGHD patients with uncontrolled pituitary tumor growth
  • 2. Tumors within 3 mm of the optic chiasm
  • 3. Serum ALT and/or AST >= 1.5 times the upper limit of normal range
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314938


Locations
Belgium
Pfizer Investigational Site
Brussel, Belgium, 1090
Pfizer Investigational Site
Bruxelles, Belgium, 1050
Pfizer Investigational Site
Edegem, Belgium, 2650
France
Pfizer Investigational Site
Paris, France, 75019
Germany
Pfizer Investigational Site
Erlangen, Germany, 91054
Israel
Pfizer Investigational Site
Petach Tikva, Israel, 49202
United Kingdom
Pfizer Investigational Site
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00314938     History of Changes
Other Study ID Numbers: A6391004
First Submitted: April 13, 2006
First Posted: April 17, 2006
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs