Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency

PHASE3TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Growth Hormone Deficiency
Interventions
DRUG

Placebo

Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.

DRUG

Somatropin

Fixed doses for patients: MALE: \< 45y 0,4 mg, \> 45y 0,2mg FEMALE: \< 45y 0,5mg, \>45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

Trial Locations (2)

80804

Pfizer Investigational Site, München

83043

Pfizer Investigational Site, Bad Aibling

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00630487 - Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency | Biotech Hunter | Biotech Hunter