Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

August 1, 2019 updated by: Ipsen

Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2
  • 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

  • Czechia
      • Brno, Czechia
        • St Ann's Faculty Hospital
      • Hradec Kralove, Czechia, 500 05
        • University Hospital Charles University
      • Prague 2, Czechia, 120 00
        • Charles University
  • France
      • Lille, France, 59037
        • Clinique Marc Linquette
      • Paris, France, 75010
        • Hôpital Lariboisière - Service de Médecine B
      • Paris, France, 75014
        • Hôpital Cochin - Service d'Endocrinologie
      • Vandoeuvre-les-Nancy, France, 54511
        • CHRU de Brabois
  • Germany
      • Berlin, Germany, 10117
        • Universitätklinikum Charité
      • Essen, Germany, 45147
        • Med. Klinik der Universitätat Essen
      • Munchen, Germany, 80336
        • Medizinische Klinik Innenstadt
  • Hong Kong
      • Pokfulam, Hong Kong
        • Queen Mary Hospital
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweiss University Medical School
      • Budapest, Hungary, 1135
        • Semmelweiss University
  • Netherlands
      • Leiden, Netherlands, 2300
        • Academic Hospital Leiden
      • Rotterdam, Netherlands, 3000
        • Academic Hospital Rotterdam
  • United Kingdom
      • Manchester, United Kingdom, M204BX
        • Christie Hospital
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
    • London
      • Hampstead, London, United Kingdom, NW3 2QG
        • The Royal Free Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Baptist Health System Inc
    • California
      • Los Angeles, California, United States, 90048
        • Pituitary Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Facility
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
    • New York
      • New York, New York, United States, 10010
        • New York University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • Ben Taub Hospital

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • documentation of a diagnosis of active acromegaly based on either of the following definitions:

    1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or
    2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)

Exclusion Criteria:

  • receipt of radiotherapy for acromegaly within 3 years
  • pituitary surgery within 3 months prior to visit 1
  • prior receipt of lanreotide autogel or GH antagonist
  • anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
  • known hypersensitivity to any of the test materials or related compounds
  • clinically significant renal or hepatic abnormalities

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

Secondary Outcome Measures

Outcome Measure
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

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

May 1, 2000

Primary Completion (Actual)

January 3, 2003

Study Completion (Actual)

January 3, 2003

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-28-52030-717

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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