Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study (SODA)
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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 |
- 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
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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 |
Patients with a clinical diagnosis of acromegaly
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| Contact: Ipsen Central Contact | clinical.trials@ipsen.com |
| United States, New Jersey | |
| Ipsen | Recruiting |
| Basking Ridge, New Jersey, United States, 07920 | |
| Study Director: | Kathleen Lomax, MD | Ipsen (formerly Tercica, Inc.) |
More Information
Additional Information:
No publications provided
| 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: | April 23, 2013 |
| 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 May 21, 2013