Clinical trial NCT00747500: Non Interventional Post Marketing Programme in Acromegaly
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Acromegaly seen in routine clinic

Brief summary: 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").


Eligibility criteria: 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).

Primary outcomes:
measure: safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional
timeFrame: End of observational period
Secondary outcomes:
measure: efficacy of Somatuline Autogel in both groups
timeFrame: End of observational period
measure: training requirements for patients / partners to perform home injection of Somatuline Autogel
timeFrame: End of observational period
measure: acceptability of home injections to patients, partners and healthcare professionals
timeFrame: End of observational period
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Barnsley
country: United Kingdom
facility: Barnsley General Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry & Warwickshire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: