Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

March 30, 2020 updated by: Ipsen

Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

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

  • France
      • Amiens, France, 80054
        • Hopital Sud
      • Angers, France, 49033
        • CHU d'Angers
      • Bois Guillaume, France, 76233
        • Hopital De Bois Guillaume
      • Caen, France, 14033
        • CHU de la cote de Nacre
      • Dijon, France, 21034
        • Hopital Du Bocage
      • Le Kremlin Bicêtre, France, 94270
        • CHU de Bicêtre
      • Limoges, France, 87042
        • Hôpital du Cluzeau
      • Lyon, France, 69394
        • Hôpital Neurologique
      • Montpellier, France, 34059
        • Hôpital Lapeyronie
      • Nice, France, 06202
        • Hôpital de l'Archet 1
      • Pessac, France, 33604
        • Hopital Du Haut-Leveque
      • Reims, France, 51092
        • Hôpital Maison Blanche
      • Rennes, France, 35056
        • Hopital Sud
      • St Etienne, France, 42055
        • Hopital Bellevue
      • Strasbourg, France, 67098
        • Hopital de Hautepierre
      • Toulouse, France, 31403
        • Hôpital de Rangueil
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Vaudois

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:

  • Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:

    • patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
    • patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.

Exclusion Criteria:

  • Patient having had pituitary surgery within the previous 3 months
  • Patient having received radiotherapy for acromegaly disease within the previous 36 months
  • Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
  • Patient having received lanreotide autogel at any time before the study

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
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)

Secondary Outcome Measures

Outcome Measure
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Mean growth hormone (GH) levels
Number of patients having a serum GH level at or below 2.5ng/ml
Number of patients having a serum GH level at or below 1 ng/ml
Number of patients with no or reduced clinical signs of acromegaly
Long-term safety of repeated injections of lanreotide autogel at titrated doses

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

September 1, 2000

Primary Completion (Actual)

July 15, 2002

Study Completion (Actual)

July 15, 2002

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-54-52030-081

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.

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