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

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00210457
Collaborator
(none)
63
Enrollment
17
Locations
22.4
Duration (Months)
3.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lanreotide (Autogel formulation)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2000
Actual Primary Completion Date :
Jul 15, 2002
Actual Study Completion Date :
Jul 15, 2002

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range []

  2. Mean growth hormone (GH) levels []

  3. Number of patients having a serum GH level at or below 2.5ng/ml []

  4. Number of patients having a serum GH level at or below 1 ng/ml []

  5. Number of patients with no or reduced clinical signs of acromegaly []

  6. Long-term safety of repeated injections of lanreotide autogel at titrated doses []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Sud Amiens France 80054
2 Chu d'Angers Angers France 49033
3 Hôpital de Bois Guillaume Bois Guillaume France 76233
4 Chu de la Cote de Nacre Caen France 14033
5 Hôpital du Bocage Dijon France 21034
6 Chu de Bicêtre Le Kremlin Bicêtre France 94270
7 Hôpital du Cluzeau Limoges France 87042
8 Hôpital Neurologique Lyon France 69394
9 Hôpital Lapeyronie Montpellier France 34059
10 Hôpital de l'Archet 1 Nice France 06202
11 Hôpital du Haut-Levêque Pessac France 33604
12 Hôpital Maison Blanche Reims France 51092
13 Hôpital Sud Rennes France 35056
14 Hôpital Bellevue St Etienne France 42055
15 Hôpital de Hautepierre Strasbourg France 67098
16 Hôpital de Rangueil Toulouse France 31403
17 Centre Hospitalier Vaudois Lausanne Switzerland CH-1011

Sponsors and Collaborators

  • Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00210457
Other Study ID Numbers:
  • E-54-52030-081
First Posted:
Sep 21, 2005
Last Update Posted:
Mar 31, 2020
Last Verified:
Mar 1, 2020
Additional relevant MeSH terms:
Acromegaly
Lanreotide

Study Results

No Results Posted as of Mar 31, 2020