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

Phase 3

Completed

• Conditions: Acromegaly

• Registration Number: NCT00210457
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2002-07-15
• Study Completion: 2002-07-15
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean growth hormone (GH) levels
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Number of patients having a serum GH level at or below 2.5ng/ml
Number of patients having a serum GH level at or below 1 ng/ml
Number of patients with no or reduced clinical signs of acromegaly
Long-term safety of repeated injections of lanreotide autogel at titrated doses

Trial Locations

Locations (16)

Centre Hospitalier Vaudois; 🇨🇭 Lausanne, Switzerland

Chu de Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

Hôpital du Bocage; 🇫🇷 Dijon, France

Hôpital Lapeyronie; 🇫🇷 Montpellier, France

Hôpital Sud; 🇫🇷 Rennes, France

Hôpital du Cluzeau; 🇫🇷 Limoges, France

Chu d'Angers; 🇫🇷 Angers, France

Hôpital de Bois Guillaume; 🇫🇷 Bois Guillaume, France

Chu de la Cote de Nacre; 🇫🇷 Caen, France

Hôpital Neurologique; 🇫🇷 Lyon, France

Hôpital Bellevue; 🇫🇷 St Etienne, France

Hôpital du Haut-Levêque; 🇫🇷 Pessac, France

Hôpital Maison Blanche; 🇫🇷 Reims, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Hôpital de l'Archet 1; 🇫🇷 Nice, France

Hôpital de Rangueil; 🇫🇷 Toulouse, France