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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00308464
First received: March 27, 2006
Last updated: May 17, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Responder status at visits 9 (week 4) and 14 (week 7), where responder is defined as a patient who has achieved an IGF-1 level above the mid-point of the age-related normal range.

Secondary Outcome Measures:
  • Change in PD and glycemic control [ Time Frame: At weeks 4 and 7 ]
  • Change in PK concentrations.
  • ALT, AST greater than 3.0 times ULN at any visit
  • Anti-hGH and anti PHA-794428 antibody production
  • Change in body weight [ Time Frame: At week 4 and follow-up ]
  • Injection site reactions

Estimated Enrollment: 136
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308464

  Hide Study Locations
Locations
Belgium
Pfizer Investigational Site
Edegem, Belgium, 2650
Pfizer Investigational Site
Gent, Belgium, 9000
Pfizer Investigational Site
Leuven, Belgium, 3000
Czech Republic
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 500 05
Pfizer Investigational Site
Praha 2, Czech Republic, 128 08
Denmark
Pfizer Investigational Site
Aarhus C, Denmark, DK-8000
Pfizer Investigational Site
Herlev, Denmark, 2730
Pfizer Investigational Site
Koebenhavn OE, Denmark, 2100
Pfizer Investigational Site
Odense C, Denmark, DK-5000
France
Pfizer Investigational Site
Marseille Cedex 5, France, 13385
Pfizer Investigational Site
Paris, France, 75013
Pfizer Investigational Site
Reims Cedex, France, 51092
Germany
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Marburg, Germany, 35043
Pfizer Investigational Site
Muenchen, Germany, 80804
Italy
Pfizer Investigational Site
Messina, Italy, 98125
Pfizer Investigational Site
Milano, Italy, 20122
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Torino, Italy, 10126
Netherlands
Pfizer Investigational Site
Leiden, Netherlands, 2333 ZA
Poland
Pfizer Investigational Site
Lodz, Poland, 93-338
Pfizer Investigational Site
Wroclaw, Poland, 50-367
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 826 06
Pfizer Investigational Site
Lubochna, Slovakia, 034 91
Spain
Pfizer Investigational Site
Santiago de Compostela, La Coruña, Spain, 15706
Pfizer Investigational Site
Alicante, Spain, 03010
Pfizer Investigational Site
Granada, Spain, 18012
Sweden
Pfizer Investigational Site
Göteborg, Sweden, 413 45
Pfizer Investigational Site
Linköping, Sweden, 581 85
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Umeå, Sweden, 901 85
United Kingdom
Pfizer Investigational Site
London, United Kingdom, EC1A 7BE
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX
Pfizer Investigational Site
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00308464     History of Changes
Other Study ID Numbers: A6391003
Study First Received: March 27, 2006
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
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

ClinicalTrials.gov processed this record on May 19, 2013