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

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ClinicalTrials.gov Identifier: NCT00858143
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : August 12, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment
Acromegaly Other: Non Interventional Observation

Detailed Description:
Non probability samples

Study Type : Observational
Actual Enrollment : 311 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: German Non Interventional Study For Patients Treated With Somavert®
Study Start Date : January 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Serious Adverse Events (SAE) and Adverse Events (AE) [ Time Frame: Baseline up to 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]
  15. 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) ]
  16. 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) ]
  17. 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) ]
  18. 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) ]
  19. 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) ]
  20. 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) ]
  21. 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) ]
  22. 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) ]
  23. 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) ]
  24. 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) ]
  25. 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) ]
  26. 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) ]
  27. 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) ]
  28. 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) ]
  29. 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) ]
  30. 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) ]
  31. 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) ]
  32. 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) ]
  33. 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) ]
  34. 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) ]
  35. 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) ]
  36. 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) ]
  37. 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) ]
  38. 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) ]
  39. 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) ]
  40. 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) ]
  41. 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) ]
  42. 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) ]
  43. 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) ]
  44. 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) ]
  45. 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) ]

Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858143


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00858143     History of Changes
Other Study ID Numbers: A6291014
First Posted: March 9, 2009    Key Record Dates
Results First Posted: August 12, 2009
Last Update Posted: September 2, 2009
Last Verified: March 2009

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