Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study - Full Text View

Sponsored by:	Tercica
Information provided by:	Tercica
ClinicalTrials.gov Identifier:	NCT00686348

Purpose

To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

Condition
Acromegaly

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-Marketing Observational Study

Further study details as provided by Tercica:

Primary Outcome Measures:

Assess the safety & effectiveness, as measured by IGF-1 & GH levels, of Somatuline® Depot Injection when administered by a health care professional, the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. [ Time Frame: 2 years/patient ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Routine clinical laboratory assessments will be performed: GH and IGF-1

Estimated Enrollment:	500
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Detailed Description:

The objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. Treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with a clinical diagnosis of acromegaly

Criteria

Inclusion Criteria:

The patient must have a clinical diagnosis of acromegaly
The patient must be treated with Somatuline® Depot (including patients newly prescribed Somatuline® Depot)
The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.

Exclusion Criteria:

Symptomatic, untreated biliary lithiasis
Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686348

Contacts

Contact: V. Miles Rios, Jr., BS, MA

1-866-837-2422

mrios@tercica.com

Locations

United States, California
Tercica, Inc.	Recruiting
Brisbane, California, United States, 94005

Sponsors and Collaborators

Tercica

Investigators

Study Director:

Sandra Blethen, MD, PhD

Tercica, Inc.

More Information

Tercica Somatuline Depot General Information This link exits the ClinicalTrials.gov site

Responsible Party:	Tercica, Inc. ( V. Miles Rios, Jr., BS, MA )
Study ID Numbers:	MS319
Study First Received:	May 27, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00686348
Health Authority:	United States: Institutional Review Board

Keywords provided by Tercica:

acromegaly

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Lanreotide
Pituitary Diseases
Musculoskeletal Diseases
Angiopeptin

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

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009