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
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)
Hôpital Sud
🇫🇷Rennes, 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
Scroll for more (6 remaining)Hôpital Sud🇫🇷Rennes, France