Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

NCT00555009 | Terminated Phase 4 Results

• 1 other identifier: A6281289
• Study Type: interventional
• Target: 10
• Locations: 6 countries
• Sites: 9

Brief Summary

To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Conditions

Brain Injuries; Growth Hormone Deficiency

Keywords

traumatic brain Injury, cognitive function

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36

  CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.

  Baseline, Week 36

Secondary Outcomes (8)

• Change From Baseline in CogState™ at Week 12 and 24.

  Baseline, Week 12 and 24

• Change From Baseline in Lean Body Mass and Fat Mass at Week 36

  Baseline, Week 36

• Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36

  Baseline, Week 36

• Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36

  Baseline, Week 36

• Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36

  Baseline, Week 36

Study Arms (2)

Genotropin treatment arm

EXPERIMENTAL

Drug: Genotropin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Genotropin DRUG

Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.

Genotropin treatment arm

Placebo DRUG

Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have had a previous traumatic brain injury (more than 1 year and less than 20 years) prior to the screening visit.
• Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.
• Have proven GHD deficiency

You may not qualify if:

• 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.
• History of dementia unrelated to TBI
• History of benign intracranial hypertension

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Créteil, 94010, France

Location

Pfizer Investigational Site

Paris, 75651, France

Location

Pfizer Investigational Site

Ferrara, 44100, Italy

Location

Pfizer Investigational Site

Roma, 00168, Italy

Location

Pfizer Investigational Site

Rotterdam, 3015 GD, Netherlands

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Gothenburg, 413 45, Sweden

Location

Pfizer Investigational Site

Stockholm, 171 76, Sweden

Location

Pfizer Investigational Site

Salford, Manchester, M6 8HD, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Brain Injuries; Dwarfism, Pituitary; Brain Injuries, Traumatic

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: November 7, 2007
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 2, 2010
• Results First Posted: June 2, 2010

Record last verified: 2009-03

Locations

IT (2); FR (2); GB (1); SE (2); NL (1); ES (1)