Clinical trial NCT02396966: Quality of Life (QoL) in Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
Official title: A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2015-03-24
Enrollment: 152
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: Specialist care clinic and hospital clinic.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Acromegaly quality of life (AcroQol) questionnaire
timeFrame: Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Secondary outcomes:
measure: Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration
timeFrame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
measure: Clinical symptoms of acromegaly
timeFrame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
measure: Patient overall assessment of satisfaction from treatment
timeFrame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
measure: Lanreotide injection interval (28, 42 or 56 days)
timeFrame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)
Other outcomes:
Locations:
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Gdansk
country: Poland
city: Gliwice
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Opole
country: Poland
city: Poznan
country: Poland
city: Rybnik
country: Poland
city: Rzeszow
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: