Placebo-controlled trial on the efficacy of growth hormone replacement therapy inpatients with growth hormone deficiency after traumatic brain injury - N/A

• Conditions: Growth hormone deficiency after traumatic brain injury; MedDRA version: 9.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

• Registration Number: EUCTR2007-003586-41-SE
• Lead Sponsor: Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Have evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Be at least 18 years of age and at the age of legal consent, and no older than 55 years of age.
3. If female, be not of child-bearing potential (i.e. surgically sterile or postmenopausal for at least one year), or be non-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) for at least one month prior to the screening visit if necessary, and for the duration of the study period.
4. Have had a previous Traumatic Brain Injury (TBI) (more than 1 year and less than 10 years) prior to the screening visit.
5. Have an Extended Glasgow Outcome Scale (GOS-E) = 5.
6. Have proven severe GH deficiency as diagnosed by dynamic testing within the last 6 months. Subjects who have had dynamic testing within a year of their brain trauma will require repeat testing prior to entrance into the study. The preference is for either using the insulin tolerance test (ITT) with a cut-off of 3 µg/l, provided that there are no contraindications, the GHRH-Arginine test with appropriate cut-off values for severe GH deficiency according to BMI, or the Glucagon test with a cut-off of 3 µg/l.
7. Have either:
a. A proven isolated GH deficiency without other pituitary hormone insufficiencies,
or
b. Be receiving stable hormone replacement therapy (excluding growth hormone
replacement) for other pituitary dysfunctions, in particular hypothyroidism and
hypocortisolism for at least 3 months prior to screening.
8. Be on stable concomitant medications for 1 month prior to entry.
9. Be likely to comply with the protocol, scheduled visits, laboratory tests and medication regimen.
10. Be fluent in the language of the investigator and study staff and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the study:
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.
7. Have a significant medical condition (e.g. renal, hepatic, respiratory, cardiovascular, hematologic, immunologic, papilloedema), which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations.
8. Diabetes mellitus requiring treatment by oral hypoglycemic agents or insulin.
9. Other severe, acute or chronic medical or psychiatric conditions or laboratory
abnormality that may increase the risk associated with study participation or may
interfere with the interpretation of study results and in the judgment of the investigator, would make the subject inappropriate for entry into this study.
10. Cognitive or neuromuscular impairment too severe to allow assessment with the
CogState™ battery.
11. Have a positive result on a urine pregnancy test at screening, or the intention to become pregnant or breastfeed during the course of the trial. Because the effects of growth hormone replacement on the fetus and developing infant are not known, subjects who are pregnant or breast-feeding will be excluded from the study.
12. Have been judged by the investigator to be medically non-compliant in the management of their treatment.
13. Have taken another investigational drug within 30 days prior to baseline.
14. Have a known or suspected drug or alcohol abuse/dependence (excluding nicotine and caffeine).
15. Known hypersensitivity to the active substance or to any of the excipients.
16. Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to establish the effects of Growth Hormone (GH) replacement in patients with severe GH deficiency after Traumatic Brain Injury (TBI) on cognitive function.;Secondary Objective: The secondary objective of this study is to establish the effect of GH replacement in subjects with severe GH deficiency after TBI on lean body mass and fat mass; Extended Glasgow-Outcome-Scale (GOS-E); SF-36 Health Survey; Assessment of Growth Hormone Deficiency in Adults (AGHDA) questionnaires and cardiovascular risk profile, as well as to demonstrate the safety of growth hormone treatment in this patient population.;Primary end point(s): The primary endpoint is the change from baseline in the CogState™ composite score at Week 36.