Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study (SODA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00686348
First received: May 27, 2008
Last updated: May 27, 2016
Last verified: May 2016
  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:


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: 260
Study Start Date: May 2008
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Ipsen
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Ipsen
Investigators
Study Director: David Cox, PhD Ipsen (formerly Tercica, Inc.)
  More Information

Additional Information:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00686348     History of Changes
Other Study ID Numbers: A-TL-52030-225 (MS319) 
Study First Received: May 27, 2008
Last Updated: May 27, 2016
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

ClinicalTrials.gov processed this record on August 25, 2016