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Completed

NCT Number: NCT00686348

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study

Acronym: SODA

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
May 29, 2008
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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