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OpenTrials
Completed

NCT Number: NCT00210457

Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

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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

Hôpital Sud, Amiens, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:
  • patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
  • patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.

Exclusion criteria

  • Patient having had pituitary surgery within the previous 3 months
  • Patient having received radiotherapy for acromegaly disease within the previous 36 months
  • Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
  • Patient having received lanreotide autogel at any time before the study

Treatment and study plan

Lanreotide (Autogel formulation)

Drug

Primary outcomes

  1. Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)

Secondary outcomes

  1. Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range

  2. Mean growth hormone (GH) levels

  3. Number of patients having a serum GH level at or below 2.5ng/ml

  4. Number of patients having a serum GH level at or below 1 ng/ml

  5. Number of patients with no or reduced clinical signs of acromegaly

  6. Long-term safety of repeated injections of lanreotide autogel at titrated doses

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Sep 21, 2005
Registry last updated
Mar 31, 2020

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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