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

Acromegaly Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210457
• Other study ID #: E-54-52030-081
• Status: Completed
• Phase: Phase 3
• Start date: September 2000
• Est. completion date: July 15, 2002

Study information

• Verified date: March 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 15, 2002
• Est. primary completion date: July 15, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Lanreotide (Autogel formulation)

Locations

Country	Name	City	State
France	Hôpital Sud	Amiens
France	Chu d'Angers	Angers
France	Hôpital de Bois Guillaume	Bois Guillaume
France	Chu de la Cote de Nacre	Caen
France	Hôpital du Bocage	Dijon
France	Chu de Bicêtre	Le Kremlin Bicêtre
France	Hôpital du Cluzeau	Limoges
France	Hôpital Neurologique	Lyon
France	Hôpital Lapeyronie	Montpellier
France	Hôpital de l'Archet 1	Nice
France	Hôpital du Haut-Levêque	Pessac
France	Hôpital Maison Blanche	Reims
France	Hôpital Sud	Rennes
France	Hôpital Bellevue	St Etienne
France	Hôpital de Hautepierre	Strasbourg
France	Hôpital de Rangueil	Toulouse
Switzerland	Centre Hospitalier Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

France,  Switzerland, 

References & Publications (1)

Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
Secondary	Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Secondary	Mean growth hormone (GH) levels
Secondary	Number of patients having a serum GH level at or below 2.5ng/ml
Secondary	Number of patients having a serum GH level at or below 1 ng/ml
Secondary	Number of patients with no or reduced clinical signs of acromegaly
Secondary	Long-term safety of repeated injections of lanreotide autogel at titrated doses