NCT00314938

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2006

Geographic Reach
5 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

Enrollment Period

1.6 years

First QC Date

April 13, 2006

Last Update Submit

May 12, 2011

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • PK, IGF-1 and safety measurements up to 2 weeks after dosing

Secondary Outcomes (1)

  • Antibody and IGFBP-3 measurements

Interventions

PHA-794428DRUG

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • \. PGHD patients with uncontrolled pituitary tumor growth
  • \. Tumors within 3 mm of the optic chiasm
  • \. Serum ALT and/or AST \>= 1.5 times the upper limit of normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Brussels, 1050, Belgium

Location

Pfizer Investigational Site

Brussels, 1090, Belgium

Location

Pfizer Investigational Site

Edegem, 2650, Belgium

Location

Pfizer Investigational Site

Paris, 75019, France

Location

Pfizer Investigational Site

Erlangen, 91054, Germany

Location

Pfizer Investigational Site

Petah Tikva, Israel, 49202, Israel

Location

Pfizer Investigational Site

Cardiff, CF14 4XN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 13, 2006

First Posted

April 17, 2006

Study Start

April 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

FR(1)DE(1)BE(3)IL(1)GB(1)