Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00499993
First received: July 11, 2007
Last updated: December 21, 2009
Last verified: December 2009
  Purpose

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.


Condition Intervention Phase
Acromegaly
Drug: lanreotide (Autogel formulation), duration of treatment 46-48 weeks
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 Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Growth hormone assessment [ Time Frame: At every visit ]

Secondary Outcome Measures:
  • Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments [ Time Frame: At every visit (with the exception of ALS at study inclusion) ]
  • Prolactin (PRL) assessment [ Time Frame: At study inclusion, visit 1 and at the final visit of the study ]
  • Lanreotide assessment [ Time Frame: At every visit ]
  • Clinical symptoms [ Time Frame: At every visit ]
  • Quality of life [ Time Frame: At visit 1 and at the final visit of the study ]
  • Tumour size [ Time Frame: At inclusion and at the final visit of the study ]
  • Evaluation of carotid vessels (on an optional basis) [ Time Frame: At inclusion and at the final visit of the study ]
  • Safety assessment evaluated by clinical data [ Time Frame: At every visit ]
  • Safety assessment evaluated by laboratory data [ Time Frame: At inclusion visit and at the final visit of the study ]

Enrollment: 63
Study Start Date: January 2001
Study Completion Date: May 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion Criteria:

  • Patients who have undergone pituitary surgery less than 3 months before selection
  • Patients previously treated with radiotherapy
  • Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499993

Locations
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Ospedale Maggiore
Bologna, Italy, 40133
Clinica Medica - Sezione II Medicina Endocrinologia
Brescia, Italy, 25125
Università deglis Studi di Cagliari
Cagliari, Italy, 09124
Ospedale Garibaldi
Catania, Italy, 95123
Università degli Studi di Ferrara
Ferrara, Italy, 44100
Università degli Studi di Firenze
Firenze, Italy, 50134
D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche
Genova, Italy, 16100
Istituto Auxologico
Milano, Italy, 20100
Ospedale Maggiore IRCCS
Milano, Italy, 20122
Ospedale di Niguarda Cà Granda
Milano, Italy, 20162
Università "Federico II" di Napoli
Napoli, Italy, 80131
Ospedale "S. Luigi Gonzaga"
Orbassano (to), Italy, 10043
Università degli Studi di Padova
Padova, Italy, 35128
Azienda Ospedaliera "V. Cervello"
Palermo, Italy, 90148
Ospedale Cisanello
Pisa, Italy, 56100
Servizio di Endocrinologia
Reggio Emilia, Italy, 42100
Università "La Sapienza" di Roma
Roma, Italy, 00161
Policlinico Agostino Gemelli
Roma, Italy, 00168
Istituto di Patologia Speciale Medica e Metodologia Clinica
Sassari, Italy, 07199
Università degli Studi di Ancona, Ospedale Umberto I
Sede Di Torrette (an) Ancona, Italy, 60020
Ospedale Molinette
Torino, Italy, 10126
Ospedale Cà Foncello
Treviso, Italy, 31100
Ospedale Santa Maria della Misericordia
Udine, Italy, 33100
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Paolo Boscani, MD Ipsen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00499993     History of Changes
Other Study ID Numbers: A-93-52030-077
Study First Received: July 11, 2007
Last Updated: December 21, 2009
Health Authority: Italy: Ministry of Health

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 August 20, 2014