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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

Last updated on December 16, 2017

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Study Location
Pfizer Investigational Site
Brussel, , 1090 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-12 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00314938
Pfizer
Terminated
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

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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
A Double Blind, Single Dose Study To Explore The Safety, Pharmacokinetics And Pharmacodynamics Of PHA-794428 In Pediatric Patients With Growth Hormone Deficiency
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Growth Hormone Deficiency
Drug: PHA-794428
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
32
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Israel,   United Kingdom
Spain
 
NCT00314938
A6391004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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