PLACEBO-CONTROLLED TRIAL ON THE EFFICACY OF GROWTH HORMONE REPLACEMENT THERAPY IN PATIENTS WITH GROWTH HORMONE DEFICIENCY AFTER TRAUMATIC BRAIN INJURY

Phase 4

Completed

• Conditions: growth hormone deficiency; 10021112

• Registration Number: NL-OMON31323
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1) Be at least 18 years of age and at the age of legal consent, and no older than 55 years of age (men and women).;2)Have had a previous TBI (more than 1 year and less than 10 years) prior to the screening visit.;3) Have proven severe GH deficiency as diagnosed by dynamic testing within the last 6 months.

Exclusion Criteria

1) Has any current malignancy except:
a. Those >5 years ago without recurrence.
b. Excised basal cell carcinoma or squamous cell cancer.
2) History of cranial irradiation.
3) Growth hormone replacement therapy in the last 12 months.
4) History of hypothalamic / pituitary disease which was diagnosed prior to TBI.
5) History of dementia unrelated to TBI.
6) History of benign intracranial hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified