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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00858143
Other study ID # A6291014
Secondary ID
Status Completed
Phase Phase 4
First received March 6, 2009
Last updated August 24, 2009
Start date January 2004
Est. completion date January 2008

Study information

Verified date March 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Ethikkommission Ethikausschuss 1 am Campus Charité Mitte
Study type Observational

Clinical Trial 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.


Description:

Non probability samples


Recruitment information / eligibility

Status Completed
Enrollment 311
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Non Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Outcome

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