A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency

NCT00308464

Last updated date
Study Location
Pfizer Investigational Site
Edegem, , 2650, Belgium
Contact
1-800-718-1021

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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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female patients with severe AGHD.

- Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.

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


- AGHD patients with uncontrolled pituitary tumor growth.


- Tumors within 3 mm of the optic chiasm.


- Patients with diabetes mellitus.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Dose Response And Safety Of PHA-794428 In Adults With Growth Hormone Deficiency
Official Title  ICMJE A Double Blind Parallel Group Randomised Multiple Dose Study To Evaluate The Pharmacodynamic Response And Safety Of PHA-794428 In Adult Growth Hormone Deficient Patients
Brief Summary The purpose of this study is to explore the safety, toleration and dose response of PHA-794428 after multiple weekly injections in male and female growth hormone deficient patients.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE Drug: PHA-794428
Study Arms  ICMJE Not Provided
Publications * Touraine P, D'Souza GA, Kourides I, Abs R, Barclay P, Xie R, Pico A, Torres-Vela E, Ekman B; GH Lipoatrophy Study Group. Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH. Eur J Endocrinol. 2009 Oct;161(4):533-40. doi: 10.1530/EJE-09-0422. Epub 2009 Aug 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: March 27, 2006)
136
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female patients with severe AGHD.
  • Hypopituitary patients must be on adequate hormone replacement therapy for at least 6 months.

Exclusion Criteria:

  • AGHD patients with uncontrolled pituitary tumor growth.
  • Tumors within 3 mm of the optic chiasm.
  • Patients with diabetes mellitus.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Netherlands,   Poland,   Slovakia,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00308464
Other Study ID Numbers  ICMJE A6391003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

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