Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency (IGHD)
2013年2月26日 更新者：Pfizer
Prospective, Randomized, Double Blind Placebo-Controlled Trial On The Efficacy Of Growth Hormone Replacement Therapy In Adult Patients With Isolated Growth Hormone Deficiency (PRO ISO-GHD Study)
The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.
研究概览
详细说明
The study was terminated on 15-Dec-2008 due to poor recruitment.
Although 9 Patients were enrolled, no patient was randomized nor treated with somatropin.
No safety reasons contributed to the termination.
研究类型
介入性
注册 (实际的)
9
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Bad Aibling、德国、83043
- Pfizer Investigational Site
-
Muenchen、德国、80804
- Pfizer Investigational Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and females between 18 and 65 years of age
- Isolated growth hormone deficiency
Exclusion Criteria:
- Isolated growth hormone deficiency by childhood onset
- Diabetes mellitus type 1 or 2
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase.
To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels.
Central lab will randomize placebo patients to dose change or maintenance of dose.
This will ensure continued blinding of the study to patients and personnel.
|
|
有源比较器：真理
|
Fixed doses for patients: MALE: < 45y 0,4 mg, > 45y 0,2mg FEMALE: < 45y 0,5mg, >45y 0,3mg.
for the first 4 weeks half of the dose will be given.
After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range.
In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks).
At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)
大体时间：Baseline, 52 weeks
|
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.
|
Baseline, 52 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Visceral Fat Mass in Subgroups
大体时间：Baseline, 52 weeks, 78 weeks
|
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).
|
Baseline, 52 weeks, 78 weeks
|
|
Change From Baseline in Anthropometric Parameters (Height)
大体时间：Baseline, 52 weeks, 78 weeks
|
Baseline, 52 weeks, 78 weeks
|
|
|
Change From Baseline in Anthropometric Parameters (Weight)
大体时间：Baseline, 52 weeks, 78 weeks
|
Baseline, 52 weeks, 78 weeks
|
|
|
Change From Baseline in Anthropometric Parameters (Waist Circumference)
大体时间：Baseline, 52 weeks, 78 weeks
|
Baseline, 52 weeks, 78 weeks
|
|
|
Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])
大体时间：Baseline, Week 52, Week 78
|
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).
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Blood Pressure
大体时间：Baseline, Week 52, Week 78
|
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.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Heart Rate
大体时间：Baseline, Week 52, Week 78
|
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.
|
Baseline, Week 52, Week 78
|
|
Change in Executive Function and Memory in Subgroups
大体时间：Baseline, Week 52, Week 78
|
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.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Safety Laboratory Assessments
大体时间：Baseline, Week 52, Week 78
|
Prespecified safety laboratory assessments evaluated for change or no change from baseline.
Possible responses were Yes/No.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Homeostasis Model Assessment (HOMA)-Index
大体时间：Baseline, Week 52, Week 78
|
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.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA)
大体时间：Baseline, Week 52, Week 78
|
Participant 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.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Short Form (36) Health Survey (SF36)
大体时间：Baseline, Week 52, Week 78
|
Participant 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.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D)
大体时间：Baseline, Week 52, Week 78
|
Participant 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'.
|
Baseline, Week 52, Week 78
|
|
Change From Baseline in Cardiovascular Risk Factors
大体时间：Baseline, Week 52, Week 78
|
Change 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)
|
Baseline, Week 52, Week 78
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年5月1日
初级完成 (实际的)
2008年10月1日
研究完成 (实际的)
2008年10月1日
研究注册日期
首次提交
2008年2月28日
首先提交符合 QC 标准的
2008年2月28日
首次发布 (估计)
2008年3月7日
研究记录更新
最后更新发布 (估计)
2013年3月4日
上次提交的符合 QC 标准的更新
2013年2月26日
最后验证
2013年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.