Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly - Full Text View

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 III

ChemIDplus related topics:

Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

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

Locations


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

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	Paolo Boscani, MD	Ipsen

More Information

Study ID Numbers:	A-93-52030-077
First Received:	July 11, 2007
Last Updated:	July 11, 2007
ClinicalTrials.gov Identifier:	NCT00499993
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Bone Diseases, Endocrine

Hypothalamic Diseases

Lanreotide

Pituitary Diseases

Musculoskeletal Diseases

Angiopeptin

Endocrine System Diseases

Central Nervous System Diseases

Endocrinopathy

Brain Diseases

Bone Diseases

Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism

Antineoplastic Agents

Therapeutic Uses

Nervous System Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00499993