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Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency

NCT00630487 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-03-04

Study results available
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Summary

The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00630487 on ClinicalTrials.gov