DRUG
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
Status
Completed
Phase
Phase 3
Enrollment
63
Locations
17
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 21, 2005
Study start
Sep 2000
Primary completion
Jul 15, 2002
Study completion
Jul 15, 2002
Results posted
Not reported
Registry updated
Mar 31, 2020
Outcomes
What the study measures.
Primary outcomes
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
Secondary outcomes
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Mean growth hormone (GH) levels
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
17 registered sites.
France · Switzerland. Showing up to 24 locations stored in the fast local snapshot.
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
Saint-Etienne, France
Hôpital de Hautepierre
Strasbourg, France
Hôpital de Rangueil
Toulouse, France
Centre Hospitalier Vaudois
Lausanne, Switzerland
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