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

January 11, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth hormone assessment
Time Frame: At every visit
At every visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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
At study inclusion, visit 1 and at the final visit of the study
Lanreotide assessment
Time Frame: At every visit
At every visit
Clinical symptoms
Time Frame: At every visit
At every visit
Quality of life
Time Frame: At visit 1 and at the final visit of the study
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
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
At inclusion and at the final visit of the study
Safety assessment evaluated by clinical data
Time Frame: At every visit
At every visit
Safety assessment evaluated by laboratory data
Time Frame: At inclusion visit and at the final visit of the study
At inclusion visit and at the final visit of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-93-52030-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acromegaly

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe