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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00858143
First received: March 6, 2009
Last updated: August 24, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Acromegaly
Other: Non Interventional Observation
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: German Non Interventional Study For Patients Treated With Somavert®

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Serious Adverse Events (SAE) and Adverse Events (AE) [ Time Frame: Baseline up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline Insulin-like Growth Factor I (IGF-I) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • IGF-I Values Within Normal Range [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • IGF-I Values Above Normal Range [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline Hemoglobin A 1c (HbA 1c) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • HbA 1c Values Within Normal Range [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • HbA 1c Values Below Normal Range [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • HbA 1c Values Above Normal Range [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline Glucose (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3) ] [ Designated as safety issue: No ]
  • Glucose Values Within Normal Range (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose Values Below Normal Range (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose Values Above Normal Range (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • IGF-I Absolute Values [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Absolute Glucose Values (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Absolute Glucose Values (2h oGTT) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Absolute Hemoglobin A 1c (HbA 1c) Values [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • HbA 1c Values Within Normal Range in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • HbA 1c Values Below Normal Range in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • HbA 1c Values Above Normal Range in Diabetic Patients [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose Change From Baseline in Diabetic Patients (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Absolute Glucose Values in Diabetic Patients (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose Values Within Normal Range in Diabetic Patients (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Glucose Values Above Normal Range in Diabetic Patients (Fasting) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) ] [ Designated as safety issue: No ]
  • Mean Change From Baseline for Body Weight [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline for Diastolic Blood Pressure (BP) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline for Systolic Blood Pressure (BP) [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Change From Baseline in Ring Size [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]
  • Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population [ Time Frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 311
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Non Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

Detailed Description:

Non probability samples

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858143

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00858143     History of Changes
Other Study ID Numbers: A6291014
Study First Received: March 6, 2009
Results First Received: June 25, 2009
Last Updated: August 24, 2009
Health Authority: Germany: Ethikkommission Ethikausschuss 1 am Campus Charité Mitte

Keywords provided by Pfizer:
Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014