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OpenTrials
Completed

NCT Number: NCT02396966

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

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bialystok, Poland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Acromegaly quality of life (AcroQol) questionnaire

    Time frame: 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 outcomes

  1. Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration

    Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)

    Descriptive analysis

  2. Clinical symptoms of acromegaly

    Time frame: 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

  3. Patient overall assessment of satisfaction from treatment

    Time frame: 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.

  4. Lanreotide injection interval (28, 42 or 56 days)

    Time frame: Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation)

    Summary of overall and by hormone control status.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: ACRO QLQ

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2015
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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