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Completed

NCT Number: NCT02807233

Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects

The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with acromegaly in daily clinical practice.

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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

Hospital de Santa Maria, Lisbon, Portugal

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women aged ≥ 18 years
  • Diagnosed with acromegaly
  • Receiving treatment with ATG 120 mg at extended dosing intervals (> 4 weeks) for at least six months before the study visit.
  • Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.
  • Able to sign the informed consent form for study participation.

Exclusion criteria

  • Received radiation therapy treatment in the last six months.
  • Active participation in another clinical study.
  • Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.
  • Pregnancy or breastfeeding for female patients.
  • No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.

Treatment and study plan

Primary outcomes

  1. Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.

    Time frame: Day 1

Secondary outcomes

  1. Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.

    Time frame: Day 1

  2. Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks.

    Time frame: Day 1

  3. Percentage of subjects whose dosing regimen has been changed in the six months before the study.

    Time frame: Day 1

  4. Preference for self-administered injections or administration in an outpatient clinic by a medical professional.

    Time frame: Day 1

  5. Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.

    Time frame: Day 1

    Total score and score per domain

  6. EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.

    Time frame: Day 1

    Total score and score per domain

  7. Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months.

    Time frame: Day 1

    Total score and score per domain

  8. Variations between theoretical and real treatment compliance for non-medical reasons.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.

Acronym: SOMACROL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 21, 2016
Registry last updated
Aug 5, 2019

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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