Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (IGHD)

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Drug: Somatropin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00630487

A6281282

Details and patient eligibility

About

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

Full description

The study was terminated on 15-Dec-2008 due to poor recruitment. Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin. No safety reasons contributed to the termination.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females between 18 and 65 years of age
• Isolated growth hormone deficiency

Exclusion criteria

• Isolated growth hormone deficiency by childhood onset
• Diabetes mellitus type 1 or 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Verum

Active Comparator group

Treatment:

Drug: Somatropin