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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00308464

Collaborator

(none)

136

Enrollment

Locations

Duration (Months)

3.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency	Drug: PHA-794428	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

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 [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 [At week 4 and follow-up]
Injection site reactions []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Edegem		Belgium	2650
2	Pfizer Investigational Site	Gent		Belgium	9000
3	Pfizer Investigational Site	Leuven		Belgium	3000
4	Pfizer Investigational Site	Hradec Kralove		Czech Republic	500 05
5	Pfizer Investigational Site	Praha 2		Czech Republic	128 08
6	Pfizer Investigational Site	Aarhus C		Denmark	DK-8000
7	Pfizer Investigational Site	Herlev		Denmark	2730
8	Pfizer Investigational Site	Koebenhavn OE		Denmark	2100
9	Pfizer Investigational Site	Odense C		Denmark	DK-5000
10	Pfizer Investigational Site	Marseille Cedex 5		France	13385
11	Pfizer Investigational Site	Paris		France	75013
12	Pfizer Investigational Site	Reims Cedex		France	51092
13	Pfizer Investigational Site	Dresden		Germany	01307
14	Pfizer Investigational Site	Marburg		Germany	35043
15	Pfizer Investigational Site	Muenchen		Germany	80804
16	Pfizer Investigational Site	Messina		Italy	98125
17	Pfizer Investigational Site	Milano		Italy	20122
18	Pfizer Investigational Site	Napoli		Italy	80131
19	Pfizer Investigational Site	Roma		Italy	00168
20	Pfizer Investigational Site	Torino		Italy	10126
21	Pfizer Investigational Site	Leiden		Netherlands	2333 ZA
22	Pfizer Investigational Site	Lodz		Poland	93-338
23	Pfizer Investigational Site	Wroclaw		Poland	50-367
24	Pfizer Investigational Site	Bratislava		Slovakia	826 06
25	Pfizer Investigational Site	Lubochna		Slovakia	034 91
26	Pfizer Investigational Site	Santiago de Compostela	La Coruña	Spain	15706
27	Pfizer Investigational Site	Alicante		Spain	03010
28	Pfizer Investigational Site	Granada		Spain	18012
29	Pfizer Investigational Site	Göteborg		Sweden	413 45
30	Pfizer Investigational Site	Linköping		Sweden	581 85
31	Pfizer Investigational Site	Lund		Sweden	221 85
32	Pfizer Investigational Site	Umeå		Sweden	901 85
33	Pfizer Investigational Site	London		United Kingdom	EC1A 7BE
34	Pfizer Investigational Site	Manchester		United Kingdom	M20 4BX
35	Pfizer Investigational Site	Oxford		United Kingdom	OX3 7LJ

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00308464

Other Study ID Numbers:

A6391003

First Posted:

Mar 29, 2006

Last Update Posted:

May 18, 2011

Last Verified:

May 1, 2011

Additional relevant MeSH terms:

Dwarfism, Pituitary

Study Results

No Results Posted as of May 18, 2011