Clinical trial NCT00858143: Non Interventional Study For Patients Treated With Somavert®
Official title: German Non Interventional Study For Patients Treated With Somavert®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Keywords: Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.

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

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.

Primary outcomes:
measure: Serious Adverse Events (SAE) and Adverse Events (AE)
timeFrame: Baseline up to 5 years
Secondary outcomes:
measure: Change From Baseline Insulin-like Growth Factor I (IGF-I)
timeFrame: 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
measure: IGF-I Values Within Normal Range
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: IGF-I Values Above Normal Range
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Change From Baseline Hemoglobin A 1c (HbA 1c)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: HbA 1c Values Within Normal Range
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: HbA 1c Values Below Normal Range
timeFrame: 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)
measure: HbA 1c Values Above Normal Range
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Change From Baseline Glucose (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
measure: Glucose Values Within Normal Range (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose Values Below Normal Range (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose Values Above Normal Range (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: IGF-I Absolute Values
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Absolute Glucose Values (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Absolute Glucose Values (2h oGTT)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Absolute Hemoglobin A 1c (HbA 1c) Values
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: HbA 1c Values Within Normal Range in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: HbA 1c Values Below Normal Range in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: HbA 1c Values Above Normal Range in Diabetic Patients
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose Change From Baseline in Diabetic Patients (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Absolute Glucose Values in Diabetic Patients (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose Values Within Normal Range in Diabetic Patients (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Glucose Values Above Normal Range in Diabetic Patients (Fasting)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
measure: Mean Change From Baseline for Body Weight
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
measure: Change From Baseline for Diastolic Blood Pressure (BP)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
measure: Change From Baseline for Systolic Blood Pressure (BP)
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
measure: Change From Baseline in Ring Size
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
measure: Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
timeFrame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: