Non Interventional Post Marketing Programme in Acromegaly

NCT00747500 | Completed

• 1 other identifier: Y-97-52030-213
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 7

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").

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

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

  End of observational period

Secondary Outcomes (3)

• efficacy of Somatuline Autogel in both groups

  End of observational period

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

  End of observational period

• acceptability of home injections to patients, partners and healthcare professionals

  End of observational period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Acromegaly seen in routine clinic

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (7)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Barnsley General Hospital

Barnsley, United Kingdom

Location

University Hospital Coventry & Warwickshire

Coventry, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

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

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

GB (7)