Skip to main content
OpenTrials
Completed

NCT Number: NCT00858143

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Non probability samples

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non Interventional Observation

Other

Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

Primary outcomes

  1. 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

  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

    Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).

  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)

    Number of participants who have IGF-I values within normal range (local laboratory, different assay).

  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)

    Number of participants who have IGF-I values above normal range (local laboratory, different assay).

  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)

    Change: HbA 1c at observation minus HbA 1c at baseline.

  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)

    Number of participants who have HbA 1c values within normal range.

  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)

    Number of participants who have HbA 1c values below normal range.

  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)

    Number of participants with HbA 1c values above normal range.

  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)

    Change: glucose at observation minus glucose at baseline.

  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)

    Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.

  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)

    Number of participants who have glucose values within normal range (fasting).

  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)

    Number of participants with glucose values below normal range (fasting).

  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)

    Number of participants with glucose values above normal range (fasting).

  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)

    Number of participants with glucose values (2h oGTT) within normal range.

  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)

    Number of participants with glucose values (2h oGTT) above normal range.

  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)

    IGF-I absolute values (local laboratory, different assay).

  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)

    Absolute Glucose values (fasting)

  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)

    Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).

  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)

    Absolute value Hemoglobin A 1c (HbA 1c)

  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)

    Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).

  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)

    Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).

  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)

    Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).

  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)

    Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).

  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)

    Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes

  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)

    Change: HbA 1c at observation minus HbA 1c at baseline.

  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)

    Number of Diabetic Patients with HbA 1c Values Within Normal Range.

  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)

    Number of Diabetic Patients with HbA 1c Values Below Normal Range

  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)

    Number of Diabetic Patients with HbA 1c Values Above Normal Range

  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)

    Change: glucose at observation minus glucose at baseline

  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)

    Absolute Glucose Values in Patients with Diabetes (fasting)

  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)

    Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range

  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)

    Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range

  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)

    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.

  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)

    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.

  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)

    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.

  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)

    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.

  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)

    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.

  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)

    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.

  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)

    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).

  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)

    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.

  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)

    Change: body weight at observation minus body weight at baseline

  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)

    Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline

  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)

    Change: systolic blood pressure at observation minus systolic blood pressure at baseline

  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)

    Change from baseline: ring size at observation minus ring size at baseline

  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)

    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.

  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)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

German Non Interventional Study For Patients Treated With Somavert®

Acronym: GPOS

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Mar 9, 2009
Registry last updated
Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.