Clinical trial NCT00210457: Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
Secondary outcomes:
measure: Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
measure: Mean growth hormone (GH) levels
measure: Number of patients having a serum GH level at or below 2.5ng/ml
measure: Number of patients having a serum GH level at or below 1 ng/ml
measure: Number of patients with no or reduced clinical signs of acromegaly
measure: Long-term safety of repeated injections of lanreotide autogel at titrated doses
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Sud
city: Angers
country: France
facility: Chu d'Angers
city: Bois Guillaume
country: France
facility: Hôpital de Bois Guillaume
city: Caen
country: France
facility: Chu de la Cote de Nacre
city: Dijon
country: France
facility: Hôpital du Bocage
city: Le Kremlin Bicêtre
country: France
facility: Chu de Bicêtre
city: Limoges
country: France
facility: Hôpital du Cluzeau
city: Lyon
country: France
facility: Hôpital Neurologique
city: Montpellier
country: France
facility: Hôpital Lapeyronie
city: Nice
country: France
facility: Hôpital de l'Archet 1
city: Pessac
country: France
facility: Hôpital du Haut-Levêque
city: Reims
country: France
facility: Hôpital Maison Blanche
city: Rennes
country: France
facility: Hôpital Sud
city: St Etienne
country: France
facility: Hôpital Bellevue
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Vaudois
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.