Trial Outcomes & Findings for Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury (NCT NCT00555009)
NCT ID: NCT00555009
Last Updated: 2010-06-02
Results Overview
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.
TERMINATED
PHASE4
10 participants
Baseline, Week 36
2010-06-02
Participant Flow
Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
Participant milestones
| Measure |
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.
|
Placebo
Matching placebo injected SC.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
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.
|
Placebo
Matching placebo injected SC.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Terminated by Sponsor
|
2
|
5
|
Baseline Characteristics
Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Genotropin
n=4 Participants
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.
|
Placebo
n=6 Participants
Matching placebo injected SC.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
18 - 44 years
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 12 and 24Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 12, 24, and 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 12, 24, and 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 4, 12, 24, and 36Population: Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.
Outcome measures
Outcome data not reported
Adverse Events
Genotropin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Genotropin
n=4 participants at risk
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.
|
Placebo
n=6 participants at risk
Matching placebo injected SC.
|
|---|---|---|
|
General disorders
Pyrexia
|
25.0%
1/4
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
25.0%
1/4
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4
|
0.00%
0/6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER