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

Primary Purpose

Acromegaly

Status

Completed

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ospedali Riuniti di Bergamo
Ospedale Maggiore
Clinica Medica - Sezione II Medicina Endocrinologia
Università deglis Studi di Cagliari
Ospedale Garibaldi
Università degli Studi di Ferrara
Università degli Studi di Firenze
D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche
Istituto Auxologico
Ospedale Maggiore IRCCS
Ospedale di Niguarda Cà Granda
Università "Federico II" di Napoli
Ospedale "S. Luigi Gonzaga"
Università degli Studi di Padova
Azienda Ospedaliera "V. Cervello"
Ospedale Cisanello
Servizio di Endocrinologia
Università "La Sapienza" di Roma
Policlinico Agostino Gemelli
Istituto di Patologia Speciale Medica e Metodologia Clinica
Università degli Studi di Ancona, Ospedale Umberto I
Ospedale Molinette
Ospedale Cà Foncello
Ospedale Santa Maria della Misericordia

Outcomes

Primary Outcome Measures

Growth hormone assessment

Secondary Outcome Measures

Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments

Prolactin (PRL) assessment

Lanreotide assessment

Clinical symptoms

Quality of life

Tumour size

Evaluation of carotid vessels (on an optional basis)

Safety assessment evaluated by clinical data

Safety assessment evaluated by laboratory data

Full Information

NCT ID

NCT00499993

First Posted

July 11, 2007

Last Updated

January 11, 2019

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT00499993

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Growth hormone assessment

Time Frame

At every visit

Secondary Outcome Measure Information:

Title

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)

Title

Prolactin (PRL) assessment

Time Frame

At study inclusion, visit 1 and at the final visit of the study

Title

Lanreotide assessment

Time Frame

At every visit

Title

Clinical symptoms

Time Frame

At every visit

Title

Quality of life

Time Frame

At visit 1 and at the final visit of the study

Title

Tumour size

Time Frame

At inclusion and at the final visit of the study

Title

Evaluation of carotid vessels (on an optional basis)

Time Frame

At inclusion and at the final visit of the study

Title

Safety assessment evaluated by clinical data

Time Frame

At every visit

Title

Safety assessment evaluated by laboratory data

Time Frame

At inclusion visit and at the final visit of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

Ospedali Riuniti di Bergamo

City

Bergamo

ZIP/Postal Code

24128

Country

Italy

Facility Name

Ospedale Maggiore

City

Bologna

ZIP/Postal Code

40133

Country

Italy

Facility Name

Clinica Medica - Sezione II Medicina Endocrinologia

City

Brescia

ZIP/Postal Code

25125

Country

Italy

Facility Name

Università deglis Studi di Cagliari

City

Cagliari

ZIP/Postal Code

09124

Country

Italy

Facility Name

Ospedale Garibaldi

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Università degli Studi di Ferrara

City

Ferrara

ZIP/Postal Code

44100

Country

Italy

Facility Name

Università degli Studi di Firenze

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

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

City

Genova

ZIP/Postal Code

16100

Country

Italy

Facility Name

Istituto Auxologico

City

Milano

ZIP/Postal Code

20100

Country

Italy

Facility Name

Ospedale Maggiore IRCCS

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Ospedale di Niguarda Cà Granda

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Università "Federico II" di Napoli

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Ospedale "S. Luigi Gonzaga"

City

Orbassano (TO)

ZIP/Postal Code

10043

Country

Italy

Facility Name

Università degli Studi di Padova

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Azienda Ospedaliera "V. Cervello"

City

Palermo

ZIP/Postal Code

90148

Country

Italy

Facility Name

Ospedale Cisanello

City

Pisa

ZIP/Postal Code

56100

Country

Italy

Facility Name

Servizio di Endocrinologia

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

Università "La Sapienza" di Roma

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Policlinico Agostino Gemelli

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Istituto di Patologia Speciale Medica e Metodologia Clinica

City

Sassari

ZIP/Postal Code

07199

Country

Italy

Facility Name

Università degli Studi di Ancona, Ospedale Umberto I

City

Sede Di Torrette (AN) Ancona

ZIP/Postal Code

60020

Country

Italy

Facility Name

Ospedale Molinette

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Ospedale Cà Foncello

City

Treviso

ZIP/Postal Code

31100

Country

Italy

Facility Name

Ospedale Santa Maria della Misericordia

City

Udine

ZIP/Postal Code

33100

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

19542735

Citation

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.

Results Reference

result

Learn more about this trial

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

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