Non Interventional Study For Patients Treated With Somavert® (GPOS)

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.

Study Overview

• Status: Completed
• Conditions: Acromegaly
• Intervention / Treatment: Other: Non Interventional Observation

Detailed Description

Non probability samples

• Study Type: Observational
• Enrollment (Actual): 311

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1	Other: Non Interventional Observation; Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events (SAE) and Adverse Events (AE)	Long term safety of Somavert in treatment of patients with acromegaly	Baseline up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Insulin-like Growth Factor I (IGF-I)	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	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	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)	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	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	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	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)	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)>	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)	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)	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)	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	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	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	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)	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)	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	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	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	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	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	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	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	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	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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)	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)	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	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	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	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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Estimate): September 2, 2009
• Last Update Submitted That Met QC Criteria: August 24, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: A6291014