Trial Outcomes & Findings for Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (NCT NCT00630487)
NCT ID: NCT00630487
Last Updated: 2013-03-04
Results Overview
Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.
TERMINATED
PHASE3
9 participants
Baseline, 52 weeks
2013-03-04
Participant Flow
Study Initiation and Completion Dates: 26 May 2008 to 17 October 2008. The study was terminated prematurely.
Nine patients were enrolled, but no patients were randomized due to early termination of study.
Participant milestones
| Measure |
Placebo
|
Somatropin
Growth hormone (GH) replacement therapy in fixed dose regimen according to age and gender: males less than or equal to 45 years receive 0.4 milligrams (mg) and females receive 0.5mg. Males greater than 45 years receive 0.2 mg and females receive 0.3 mg.
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|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline, 52 weeksPopulation: Study terminated, no subjects were treated.
Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 52 weeks, 78 weeksPopulation: Study terminated, no subjects were treated.
Change in visceral fat mass in subgroups. Subgroup 1: isolated GHD due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 52 weeks, 78 weeksPopulation: Study terminated, no subjects were treated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 52 weeks, 78 weeksPopulation: Study terminated, no subjects were treated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 52 weeks, 78 weeksPopulation: Study terminated, no subjects were treated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: Study terminated, no subjects were treated.
Alertness: software-based neuropsychological assessment for response time and errors. Memory: analysis of learning and retention using 5-trial presentation of 15-word list (A), single presentation of interference list (B), 2 postinterference recall trials - 1 immediate, 1 delayed - and recognition of the target words with distractors (C). Performance variables were immediate word span under overload conditions, final acquisition level, amount learned in 5 trials, interference, delayed recall, and recognition (implicit learning).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: Study terminated, no subjects were treated.
Blood pressure was measured seated, the subject's arm supported at the level of the heart, and recorded to the nearest mm Hg. The same arm (preferably the dominant arm) was used throughout the trial. The subject was seated for 5 minutes before the blood pressure was obtained. Use of an automated device could have been used for measuring blood pressure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: Study terminated, no subjects were treated.
The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: Study terminated, no subjects were treated.
Change in executive function and memory in subgroups. Subgroup 1: isolated Growth Hormone Deficiency (GHD)due to surgery and/or irradiation of pituitary adenoma and suprasellar tumors. Subgroup 2: history of traumatic brain injury (TBI) or subarachnoid hemorrhage (SAH). Median reaction time, the total number of errors, the number of omissions and the number of false positive reactions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Prespecified safety laboratory assessments evaluated for change or no change from baseline. Possible responses were Yes/No.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Population: Study terminated, no subjects were treated.
HOMA index is calculated by 1 of 2 methods: HOMA-Index = fasting insulin measured in microunits per milliliter (µU/ml) times fasting glucose measured in milligrams per deciliter mg/dl) divided by 405 or HOMA-Index = fasting insulin (µU/ml) times fasting glucose measured in millimoles per liter (mmol/l) divided by 22.5.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Participant self administered questionnaire consisting of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Participant self administered questionnaire that measures each of the following eight health concepts: Physical Functioning (PF); Role-Physical (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role-Emotional (RE); Mental Health (MH) as well as a reported Health Transition item (HT). Scale range 0 to 100, higher scores indicate a better health-related quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Participant self-administered questionnaire EQ-5D, a 2 part generic health status instrument. The first part consists of 5 descriptors of current health state: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Scores are assigned on a three-level scale (1= no problem, 2= some problem, 3= extreme problem). The second part was an overall rating of the participant's current health state using a 20 cm Visual Analogue Scale (EQ-VAS) with endpoints labelled 'best imaginable health state' and 'worst imaginable health state'.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 52, Week 78Change in values of laboratory tests indicative of possible cardiovascular risk factors: high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, N-terminal pro brain natriuretic peptide)
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Somatropin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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 info other than study results.
- Publication restrictions are in place
Restriction type: OTHER