Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

Completed

• Conditions: Acromegaly

• Registration Number: NCT02396966
• Lead Sponsor: Ipsen

Brief Summary

The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-24
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion.
• Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.

Exclusion Criteria

• Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria).
• Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acromegaly quality of life (AcroQol) questionnaire	Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)	The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery.

Secondary Outcome Measures

Name	Time	Method
Clinical symptoms of acromegaly	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)	Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling
Lanreotide injection interval (28, 42 or 56 days)	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)	Summary of overall and by hormone control status.
Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)	Descriptive analysis
Patient overall assessment of satisfaction from treatment	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)	Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied.