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Trial record 1 of 1 for:    NCT00858143
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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

Tracking Information
First Submitted Date March 6, 2009
First Posted Date March 9, 2009
Results First Submitted Date June 25, 2009
Results First Posted Date August 12, 2009
Last Update Posted Date September 2, 2009
Study Start Date January 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 24, 2009)		 Serious Adverse Events (SAE) and Adverse Events (AE) [ Time Frame: Baseline up to 5 years ]
Original Primary Outcome Measures
 (submitted: March 6, 2009)		 The assessment of long-term safety of Somavert® in treatment of subjects with acromegaly. [ Time Frame: 4 years ]
Change History Complete list of historical versions of study NCT00858143 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 24, 2009)
  • 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 ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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 (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 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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 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 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 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 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 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 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 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) ]
  • 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 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 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 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) ]
  • 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 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) ]
Original Secondary Outcome Measures
 (submitted: March 6, 2009)
  • Long term effectiveness [ Time Frame: 4 years ]
  • Recording of the effects of Somavert® treatment on the concomitant diseases associated with the clinical syndrome of acromegaly. [ Time Frame: 4 years ]
  • Recording of relationships between the concentration of IGF-I in serum and the concomitant diseases associated with the clinical syndrome of acromegaly. [ Time Frame: 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non Interventional Study For Patients Treated With Somavert®
Official Title German Non Interventional Study For Patients Treated With Somavert®
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.
Detailed Description Non probability samples
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
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.
Condition Acromegaly
Intervention Other: Non Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
Study Groups/Cohorts 1
Intervention: Other: Non Interventional Observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 6, 2009)		 311
Original Actual Enrollment Same as current
Actual Study Completion Date January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00858143
Other Study ID Numbers A6291014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2009