Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

August 14, 2019 updated by: Ipsen

A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

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

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of acromegaly
  • The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
  • The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
  • Life expectancy of at least 2 years

Exclusion Criteria:

  • Adenectomy within past 6 months, or likely during study period
  • Radiotherapy for acromegalic disease within 1 year, or likely during study period
  • Unstable concomitant dopamine agonist therapy

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
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary Outcome Measures

Outcome Measure
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Change in the GH values compared to the baseline (Week 0) visit.
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Change in the serum octreotide levels compared to the baseline visit.
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

Collaborators and Investigators

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

Sponsor

Ipsen

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

June 1, 2004

Primary Completion (Actual)

June 22, 2006

Study Completion (Actual)

June 22, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-9B-52030-159

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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