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

NCT ID: NCT00499993

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lanreotide (Autogel formulation), duration of treatment 46-48 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Ospedali Riuniti di Bergamo

Bergamo, , Italy

Site Status

Ospedale Maggiore

Bologna, , Italy

Site Status

Clinica Medica - Sezione II Medicina Endocrinologia

Brescia, , Italy

Site Status

Università deglis Studi di Cagliari

Cagliari, , Italy

Site Status

Ospedale Garibaldi

Catania, , Italy

Site Status

Università degli Studi di Ferrara

Ferrara, , Italy

Site Status

Università degli Studi di Firenze

Florence, , Italy

Site Status

D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche

Genova, , Italy

Site Status

Istituto Auxologico

Milan, , Italy

Site Status

Ospedale Maggiore IRCCS

Milan, , Italy

Site Status

Ospedale di Niguarda Cà Granda

Milan, , Italy

Site Status

Università "Federico II" di Napoli

Napoli, , Italy

Site Status

Ospedale "S. Luigi Gonzaga"

Orbassano (TO), , Italy

Site Status

Università degli Studi di Padova

Padua, , Italy

Site Status

Azienda Ospedaliera "V. Cervello"

Palermo, , Italy

Site Status

Ospedale Cisanello

Pisa, , Italy

Site Status

Servizio di Endocrinologia

Reggio Emilia, , Italy

Site Status

Università "La Sapienza" di Roma

Roma, , Italy

Site Status

Policlinico Agostino Gemelli

Roma, , Italy

Site Status

Istituto di Patologia Speciale Medica e Metodologia Clinica

Sassari, , Italy

Site Status

Università degli Studi di Ancona, Ospedale Umberto I

Sede Di Torrette (AN) Ancona, , Italy

Site Status

Ospedale Molinette

Torino, , Italy

Site Status

Ospedale Cà Foncello

Treviso, , Italy

Site Status

Ospedale Santa Maria della Misericordia

Udine, , Italy

Site Status

Countries

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Italy

References

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Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest. 2009 Mar;32(3):202-9. doi: 10.1007/BF03346453.

Reference Type RESULT
PMID: 19542735 (View on PubMed)

Other Identifiers

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A-93-52030-077

Identifier Type: -

Identifier Source: org_study_id

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