Back to resultsEfficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lanreotide (Autogel formulation)
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
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
Sites / Locations
- Hôpital Sud
- Chu d'Angers
- Hôpital de Bois Guillaume
- Chu de la Cote de Nacre
- Hôpital du Bocage
- Chu de Bicêtre
- Hôpital du Cluzeau
- Hôpital Neurologique
- Hôpital Lapeyronie
- Hôpital de l'Archet 1
- Hôpital du Haut-Levêque
- Hôpital Maison Blanche
- Hôpital Sud
- Hôpital Bellevue
- Hôpital de Hautepierre
- Hôpital de Rangueil
- Centre Hospitalier Vaudois
Outcomes
Primary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00210457
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
July 15, 2002 (Actual)
Study Completion Date
July 15, 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lanreotide (Autogel formulation)
Primary Outcome Measure Information:
Title
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
Secondary Outcome Measure Information:
Title
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Title
Mean growth hormone (GH) levels
Title
Number of patients having a serum GH level at or below 2.5ng/ml
Title
Number of patients having a serum GH level at or below 1 ng/ml
Title
Number of patients with no or reduced clinical signs of acromegaly
Title
Long-term safety of repeated injections of lanreotide autogel at titrated doses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Chu d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hôpital de Bois Guillaume
City
Bois Guillaume
ZIP/Postal Code
76233
Country
France
Facility Name
Chu de la Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Chu de Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
Hôpital du Cluzeau
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital Neurologique
City
Lyon
ZIP/Postal Code
69394
Country
France
Facility Name
Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34059
Country
France
Facility Name
Hôpital de l'Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôpital du Haut-Levêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpital Sud
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Hôpital Bellevue
City
St Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital de Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Centre Hospitalier Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
18248639
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.
Results Reference
result
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Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
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