German Non Interventional Study For Patients Treated With Somavert®

Pfizer0 sites311 target enrollmentJanuary 2004

ConditionsAcromegaly

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acromegaly
Sponsor: Pfizer
Enrollment: 311
Primary Endpoint: Serious Adverse Events (SAE) and Adverse Events (AE)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Detailed Description

Non probability samples

Registry

clinicaltrials.gov

Start Date

January 2004

End Date

January 2008

Last Updated

16 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Serious Adverse Events (SAE) and Adverse Events (AE)

Time Frame: Baseline up to 5 years

Long term safety of Somavert in treatment of patients with acromegaly

Secondary Outcomes

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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
Change From Baseline for Diastolic Blood Pressure (BP)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5))
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)
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))
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(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 (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(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(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(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 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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
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))
Mean Change From Baseline for Body Weight(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5))
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))
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))
Change From Baseline for Systolic Blood Pressure (BP)(Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5))
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))
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))
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))
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))