Non Interventional Study For Patients Treated With Somavert® - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00858143

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 IV

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

The assessment of long-term safety of Somavert® in treatment of subjects with acromegaly. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Long term effectiveness [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Recording of the effects of Somavert® treatment on the concomitant diseases associated with the clinical syndrome of acromegaly. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6291014
Study First Received:	March 6, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858143 History of Changes
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

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Musculoskeletal Diseases
Endocrine System Diseases

Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Bone Diseases, Endocrine
Hypothalamic Diseases
Hyperpituitarism
Pituitary Diseases
Musculoskeletal Diseases
Nervous System Diseases

Endocrine System Diseases
Central Nervous System Diseases
Brain Diseases
Bone Diseases
Acromegaly

ClinicalTrials.gov processed this record on May 06, 2009