Primary outcomeMean· Baseline, Week 36
Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36
| Group | Value (scores on a scale) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataTreatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
NCTNCT00555009 (opens ClinicalTrials.gov in a new tab)Other idA6281289
This trial was stopped early.
Reason given at the registry: See termination reason in detailed description.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 10 participants (actual)
- Sponsor
- Pfizer · Industry
- Design
- Randomized · Double masking
- Countries
6 countries
France, Italy, Netherlands, Spain, Sweden, United Kingdom
- Start
- Mar 2008
- Primary completion
- Jan 2009
- Completion
- Jan 2009
- First posted
- 7 Nov 2007 (estimated)
- Last update posted
- 2 Jun 2010 (estimated)
- Conditions
- Brain Injuries · Growth Hormone Deficiency
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 4Terminated
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
NCT00555009Mar 2008 to Jan 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
Interventions
- GenotropinDrug
- PlaceboDrug
Arms2
Experimental
Genotropin treatment arm
Placebo comparator
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36
Time frame · Baseline, Week 36
Registry description
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.
Secondary outcomes(8)
Change From Baseline in CogState™ at Week 12 and 24.
Time frame · Baseline, Week 12 and 24
Registry description
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.
Change From Baseline in Lean Body Mass and Fat Mass at Week 36
Time frame · Baseline, Week 36
Registry description
The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.
Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36
Time frame · Baseline, Week 36
Registry description
The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery
Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36
Time frame · Baseline, Week 36
Registry description
A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.
Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36
Time frame · Baseline, Week 36
Registry description
The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 'Yes' or 'No' statements covering 6 dimensions - mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.
Change From Baseline in Cardiovascular Risk
Time frame · Baseline, Weeks 2, 4, 12, 24, and 36
Registry description
The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).
Change From Baseline in Weight
Time frame · Baseline, Weeks 2, 4, 12, 24, and 36
Change From Baseline in Waist Circumference
Time frame · Baseline, Weeks 2, 4, 12, 24, and 36
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Week 12 and 24
Change From Baseline in CogState™ at Week 12 and 24.
| Group | Value (scores on a scale) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline, Week 36
Change From Baseline in Lean Body Mass and Fat Mass at Week 36
| Group | Value (kg) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline, Week 36
Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36
| Group | Value (scores on a scale) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline, Week 36
Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36
| Group | Value (score on a scale) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline, Week 36
Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36
| Group | Value (scores on a scale) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline, Weeks 2, 4, 12, 24, and 36
Change From Baseline in Cardiovascular Risk
| Group | Value (scores on a scale) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Secondary outcomeMean· Baseline, Weeks 2, 4, 12, 24, and 36
Change From Baseline in Weight
| Group | Value (kg) |
|---|---|
| Genotropin | not posted |
| Placebo | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| GenotropinInitiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range. | – | 0 / 4 | 4 / 4 |
| PlaceboMatching placebo injected SC. | – | 0 / 6 | 0 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* 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
Exclusion Criteria:
* Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.
* 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
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