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See termination reason in detailed description.
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To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.
The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotropin treatment arm | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Cognitive Function (CogStateâ„¢) Composite Score at Week 36 | CogStateâ„¢: 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CogStateâ„¢ at Week 12 and 24. | CogStateâ„¢: 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Créteil | 94010 | France | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Genotropin | Initiated 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. |
| FG001 | Placebo | Matching placebo injected SC. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Genotropin | Initiated 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Cognitive Function (CogStateâ„¢) Composite Score at Week 36 | CogStateâ„¢: 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. | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 36 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genotropin | Initiated 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D004393 | Dwarfism, Pituitary |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Placebo | Drug | Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks. |
|
| Baseline, Week 12 and 24 |
| Change From Baseline in Lean Body Mass and Fat Mass at Week 36 | 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. | Baseline, Week 36 |
| Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 | 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 | Baseline, Week 36 |
| Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 | 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. | Baseline, Week 36 |
| Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 | 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. | Baseline, Week 36 |
| Change From Baseline in Cardiovascular Risk | 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). | Baseline, Weeks 2, 4, 12, 24, and 36 |
| Change From Baseline in Weight | Baseline, Weeks 2, 4, 12, 24, and 36 |
| Change From Baseline in Waist Circumference | Baseline, Weeks 2, 4, 12, 24, and 36 |
| Paris |
| 75651 |
| France |
| Pfizer Investigational Site | Ferrara | 44100 | Italy |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Rotterdam | 3015 GD | Netherlands |
| Pfizer Investigational Site | Seville | Sevilla | 41013 | Spain |
| Pfizer Investigational Site | Gothenburg | 413 45 | Sweden |
| Pfizer Investigational Site | Stockholm | 171 76 | Sweden |
| Pfizer Investigational Site | Salford | Manchester | M6 8HD | United Kingdom |
Matching placebo injected SC.
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Matching placebo injected SC. |
|
| Secondary | Change From Baseline in CogStateâ„¢ at Week 12 and 24. | CogStateâ„¢: 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. | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 12 and 24 |
|
|
|
| Secondary | Change From Baseline in Lean Body Mass and Fat Mass at Week 36 | 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. | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | kg | Baseline, Week 36 |
|
|
| Secondary | Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 | 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 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 36 |
|
|
| Secondary | Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 | 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. | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 36 |
|
|
| Secondary | Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 | 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. | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 36 |
|
|
| Secondary | Change From Baseline in Cardiovascular Risk | 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). | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Weeks 2, 4, 12, 24, and 36 |
|
|
|
| Secondary | Change From Baseline in Weight | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | kg | Baseline, Weeks 2, 4, 12, 24, and 36 |
|
|
|
| Secondary | Change From Baseline in Waist Circumference | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | Posted | Mean | Standard Deviation | cm | Baseline, Weeks 2, 4, 12, 24, and 36 |
|
|
|
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Placebo | Matching placebo injected SC. | 0 | 6 | 0 | 6 |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |