Non Interventional Study For Patients Treated With Somavert® (GPOS)
2009年8月24日 更新者：Pfizer
German Non Interventional Study For Patients Treated With Somavert®
This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.
研究概览
详细说明
Non probability samples
研究类型
观察性的
注册 (实际的)
311
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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
描述
Inclusion Criteria:
- Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Exclusion Criteria:
- Subjects treated with an investigational drug for treatment of acromegaly.
- Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery.
- Women who were pregnant or lactating.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
1个
|
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
|
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 |
|---|---|---|
|
Serious Adverse Events (SAE) and Adverse Events (AE)
大体时间：Baseline up to 5 years
|
Long term safety of Somavert in treatment of patients with acromegaly
|
Baseline up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
大体时间：Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months
|
Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
|
Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months
|
|
IGF-I Values Within Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have IGF-I values within normal range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
IGF-I Values Above Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have IGF-I values above normal range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: HbA 1c at observation minus HbA 1c at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
HbA 1c Values Within Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have HbA 1c values within normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
HbA 1c Values Below Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)
|
Number of participants who have HbA 1c values below normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)
|
|
HbA 1c Values Above Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with HbA 1c values above normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Change From Baseline Glucose (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: glucose at observation minus glucose at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
|
Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
|
|
Glucose Values Within Normal Range (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have glucose values within normal range (fasting).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose Values Below Normal Range (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values below normal range (fasting).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose Values Above Normal Range (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values above normal range (fasting).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values (2h oGTT) within normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values (2h oGTT) above normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
IGF-I Absolute Values
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
IGF-I absolute values (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Absolute Glucose Values (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose values (fasting)
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Absolute Glucose Values (2h oGTT)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Absolute Hemoglobin A 1c (HbA 1c) Values
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute value Hemoglobin A 1c (HbA 1c)
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: IGF-I concentration at observation minus IGF-I concentration at baseline.
(local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: HbA 1c at observation minus HbA 1c at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
HbA 1c Values Within Normal Range in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with HbA 1c Values Within Normal Range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
HbA 1c Values Below Normal Range in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with HbA 1c Values Below Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
HbA 1c Values Above Normal Range in Diabetic Patients
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with HbA 1c Values Above Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: glucose at observation minus glucose at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Absolute Glucose Values in Diabetic Patients (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose Values in Patients with Diabetes (fasting)
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs.
Scoring 0-10 (0 = worst and 10 = best possible).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Total PASQ score: total score calculated as sum of items 1-6; range is 0-48.
Change from baseline calculated as total score at observation minus total score at baseline.
PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
|
Mean Change From Baseline for Body Weight
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change: body weight at observation minus body weight at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
|
Change From Baseline for Diastolic Blood Pressure (BP)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
|
Change From Baseline for Systolic Blood Pressure (BP)
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change: systolic blood pressure at observation minus systolic blood pressure at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
|
Change From Baseline in Ring Size
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change from baseline: ring size at observation minus ring size at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy.
Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration.
Model included terms for IGF-I, growth hormone, age, weight and gender.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
|
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
大体时间：Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy.
Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration.
Model included terms for IGF-I, growth hormone, age, weight and gender.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
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
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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
2004年1月1日
初级完成 (实际的)
2008年1月1日
研究完成 (实际的)
2008年1月1日
研究注册日期
首次提交
2009年3月6日
首先提交符合 QC 标准的
2009年3月6日
首次发布 (估计)
2009年3月9日
研究记录更新
最后更新发布 (估计)
2009年9月2日
上次提交的符合 QC 标准的更新
2009年8月24日
最后验证
2009年3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.
Non Interventional Observation的临床试验
-
Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust完全的
-
Charite University, Berlin, Germany招聘中