Trial · NCT00555009
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
NCT00555009, Phase 4, Terminated, Pfizer; results first posted 2010-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury. Trials, record NCT00555009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00555009
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
- NCT number
- NCT00555009
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 10 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Brain Injuries, Growth Hormone Deficiency
- Interventions
- Genotropin, Placebo
- First posted
- 2007-11-07
- Last updated
- 2010-06-02
- Results first posted
- 2010-06-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 | Baseline, 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. |
| Secondary | Change From Baseline in CogState™ at Week 12 and 24. | Baseline, Week 12 and 24 | 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 | Change From Baseline in Lean Body Mass and Fat Mass at Week 36 | Baseline, 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. |
| Secondary | Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 | Baseline, 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 |
| Secondary | Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 | Baseline, 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. |
| Secondary | Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 | Baseline, 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. |
| Secondary | Change From Baseline in Cardiovascular Risk | Baseline, Weeks 2, 4, 12, 24, and 36 | 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). |
| Secondary | Change From Baseline in Weight | Baseline, Weeks 2, 4, 12, 24, and 36 | |
| Secondary | Change From Baseline in Waist Circumference | Baseline, Weeks 2, 4, 12, 24, and 36 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36 | Baseline, Week 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in CogState™ at Week 12 and 24. | Baseline, Week 12 and 24 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Lean Body Mass and Fat Mass at Week 36 | Baseline, Week 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | kg | MEAN |
| SECONDARY | Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36 | Baseline, Week 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36 | Baseline, Week 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | score on a scale | MEAN |
| SECONDARY | Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36 | Baseline, Week 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Cardiovascular Risk | Baseline, Weeks 2, 4, 12, 24, and 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Weight | Baseline, Weeks 2, 4, 12, 24, and 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | kg | MEAN |
| SECONDARY | Change From Baseline in Waist Circumference | Baseline, Weeks 2, 4, 12, 24, and 36 | Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed. | cm | MEAN |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in CogState™ at Week 12 and 24. | Group not reported | Week 12 | scores on a scale | ||
| Change From Baseline in CogState™ at Week 12 and 24. | Group not reported | Week 24 | scores on a scale | ||
| Change From Baseline in Cardiovascular Risk | Group not reported | Week 2 | scores on a scale | ||
| Change From Baseline in Cardiovascular Risk | Group not reported | Week 4 | scores on a scale | ||
| Change From Baseline in Cardiovascular Risk | Group not reported | Week 12 | scores on a scale | ||
| Change From Baseline in Cardiovascular Risk | Group not reported | Week 24 | scores on a scale | ||
| Change From Baseline in Cardiovascular Risk | Group not reported | Week 36 | scores on a scale | ||
| Change From Baseline in Weight | Group not reported | Week 2 | kg | ||
| Change From Baseline in Weight | Group not reported | Week 4 | kg | ||
| Change From Baseline in Weight | Group not reported | Week 12 | kg |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Genotropin | 4 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Genotropin | 2 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Genotropin | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Genotropin | 1 | 4 | |
| other | Pyrexia | General disorders | Placebo | 0 | 6 | |
| other | Lower limb fracture | Injury, poisoning and procedural complications | Genotropin | 1 | 4 | |
| other | Lower limb fracture | Injury, poisoning and procedural complications | Placebo | 0 | 6 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Genotropin | 1 | 4 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 0 | 6 | |
| other | Somnolence | Nervous system disorders | Genotropin | 1 | 4 | |
| other | Somnolence | Nervous system disorders | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Genotropin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Genotropin | 4 | 4 |
| Total, other adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Genotropin | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Genotropin vs Placebo: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| 1-Back Task | Primary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00555009
GET https://conductscience.org/api/trials/v1/NCT00555009/registered