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

Sponsor:	Ipsen
Information provided by (Responsible Party):	Ipsen
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

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

Resource links provided by NLM:

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Further study details as provided by Ipsen:

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 - 4 years/patient ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

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

Enrollment:	160
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (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

Locations

United States, California
Ipsen
Brisbane, California, United States, 94005

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Bert Bakker, MD, PhD

Ipsen (formerly Tercica, Inc.)

More Information

Additional Information:

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

No publications provided

Responsible Party:	Ipsen
ClinicalTrials.gov Identifier:	NCT00686348 History of Changes
Other Study ID Numbers:	MS319
Study First Received:	May 27, 2008
Last Updated:	September 20, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ipsen:

acromegaly

Additional relevant MeSH terms:

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

Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012