Acromegaly Clinical Trial
— GPOSOfficial title:
German Non Interventional Study For Patients Treated With Somavert®
Verified date | March 2009 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethikkommission Ethikausschuss 1 am Campus Charité Mitte |
Study type | Observational |
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.
Status | Completed |
Enrollment | 311 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serious Adverse Events (SAE) and Adverse Events (AE) | Baseline up to 5 years | Yes | |
Secondary | Change From Baseline Insulin-like Growth Factor I (IGF-I) | 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 | No | |
Secondary | IGF-I 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) | No | |
Secondary | IGF-I 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) | No | |
Secondary | Change From Baseline 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) | No | |
Secondary | 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) | No | |
Secondary | 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) | No | |
Secondary | 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) | No | |
Secondary | Change From Baseline Glucose (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) | No | |
Secondary | Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3) | No | |
Secondary | 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) | No | |
Secondary | 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) | No | |
Secondary | 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) | No | |
Secondary | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) 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) | No | |
Secondary | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) 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) | No | |
Secondary | IGF-I Absolute Values | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | 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) | No | |
Secondary | Absolute Glucose Values (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) | No | |
Secondary | Absolute Hemoglobin A 1c (HbA 1c) Values | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | HbA 1c Values Within Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | HbA 1c Values Below Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | HbA 1c Values Above Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Glucose Change From Baseline in Diabetic Patients (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) | No | |
Secondary | Absolute Glucose Values in Diabetic Patients (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) | No | |
Secondary | Glucose Values Within Normal Range in Diabetic Patients (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) | No | |
Secondary | Glucose Values Above Normal Range in Diabetic Patients (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) | No | |
Secondary | Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | No | |
Secondary | Mean Change From Baseline for Body Weight | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | No | |
Secondary | Change From Baseline for Diastolic Blood Pressure (BP) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | No | |
Secondary | Change From Baseline for Systolic Blood Pressure (BP) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | No | |
Secondary | Change From Baseline in Ring Size | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No | |
Secondary | Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | No |
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