Acromegaly
Conditions
Keywords
acromegaly
Brief summary
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.
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 - 4 years/patient |
Countries
United States
Outcome results
None listed