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

Acromegaly Clinical Trial

— ACRO QLQ  

Official title:

A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396966
• Other study ID #: A-38-52030-306
• Status: Completed
• Start date: December 2014
• Est. completion date: May 2018

Study information

• Verified date: December 2018
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acromegaly quality of life (AcroQol) questionnaire	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.	Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Secondary	Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration	Descriptive analysis	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Secondary	Clinical symptoms of acromegaly	Descriptive analysis of the following symptoms - Headache, Sweating, Joint symptoms and Swelling	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Secondary	Patient overall assessment of satisfaction from treatment	Using a Likert scale (from 1 to 5); completely satisfied, rather satisfied, neither satisfied nor dissatisfied, rather dissatisfied, completely dissatisfied.	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Secondary	Lanreotide injection interval (28, 42 or 56 days)	Summary of overall and by hormone control status.	Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)