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OpenTrials
Completed

NCT Number: NCT00499993

Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

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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

Interventional

Phase

Phase 3

Primary location

Ospedali Riuniti di Bergamo, Bergamo, Italy

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion criteria

  • Patients who have undergone pituitary surgery less than 3 months before selection
  • Patients previously treated with radiotherapy
  • Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months

Treatment and study plan

lanreotide (Autogel formulation), duration of treatment 46-48 weeks

Drug

Primary outcomes

  1. Growth hormone assessment

    Time frame: At every visit

Secondary outcomes

  1. Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments

    Time frame: At every visit (with the exception of ALS at study inclusion)

  2. Prolactin (PRL) assessment

    Time frame: At study inclusion, visit 1 and at the final visit of the study

  3. Lanreotide assessment

    Time frame: At every visit

  4. Clinical symptoms

    Time frame: At every visit

  5. Quality of life

    Time frame: At visit 1 and at the final visit of the study

  6. Tumour size

    Time frame: At inclusion and at the final visit of the study

  7. Evaluation of carotid vessels (on an optional basis)

    Time frame: At inclusion and at the final visit of the study

  8. Safety assessment evaluated by clinical data

    Time frame: At every visit

  9. Safety assessment evaluated by laboratory data

    Time frame: At inclusion visit and at the final visit of the study

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly

Important dates

Study start
2001
Study completion
2003
First posted
Jul 12, 2007
Registry last updated
Jan 15, 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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