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OpenTrials
Completed

NCT Number: NCT00747500

Non Interventional Post Marketing Programme in Acromegaly

The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis.
  • The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
  • The patient must have a diagnosis of acromegaly.
  • The patient must be at least 18 years of age.
  • For patients receiving or intending to receive Somatuline Autogel by home injection:
  • The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service.

Exclusion criteria

  • The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).

Treatment and study plan

Primary outcomes

  1. safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional

    Time frame: End of observational period

Secondary outcomes

  1. efficacy of Somatuline Autogel in both groups

    Time frame: End of observational period

  2. training requirements for patients / partners to perform home injection of Somatuline Autogel

    Time frame: End of observational period

  3. acceptability of home injections to patients, partners and healthcare professionals

    Time frame: End of observational period

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals.

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Sep 5, 2008
Registry last updated
Jan 7, 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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