Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00210457
First received: September 19, 2005
Last updated: June 26, 2008
Last verified: June 2008
History of Changes
  Purpose

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 Intervention Phase
Acromegaly
 Drug: Lanreotide (Autogel formulation)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

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

Estimated Enrollment: 60
Study Start Date: September 2000
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210457

Locations
France
Hôpital Sud
Amiens, France, 80054
Chu d'Angers
Angers, France, 49033
Hôpital de Bois Guillaume
Bois Guillaume, France, 76233
Chu de la Cote de Nacre
Caen, France, 14033
Hôpital du Bocage
Dijon, France, 21034
Chu de Bicêtre
Le Kremlin Bicêtre, France, 94270
Hôpital du Cluzeau
Limoges, France, 87042
Hôpital Neurologique
Lyon, France, 69394
Hôpital Lapeyronie
Montpellier, France, 34059
Hôpital de l'Archet 1
Nice, France, 06202
Hôpital du Haut-Levêque
Pessac, France, 33604
Hôpital Maison Blanche
Reims, France, 51092
Hôpital Sud
Rennes, France, 35056
Hôpital Bellevue
St Etienne, France, 42055
Hôpital de Hautepierre
Strasbourg, France, 67098
Hôpital de Rangueil
Toulouse, France, 31403
Switzerland
Centre Hospitalier Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Joelle Blumberg, MD Ipsen
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00210457     History of Changes
Other Study ID Numbers: E-54-52030-081 (311)
Study First Received: September 19, 2005
Last Updated: June 26, 2008
Health Authority: France: Ministry of Health
Switzerland: Intercantonal Office for the Control of Medicines (IOCM)

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013