Somatuline Autogel: Acromegaly Self/Partner Injection Study

August 1, 2019 updated by: Ipsen

A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.

The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Dept of Endocrinology, Aberdeen Royal Infirmary
      • Birmingham, United Kingdom, B15 2TH
        • Department of Medicine, Queen Elizabeth Hospital
      • Coventry, United Kingdom, CV1 4FH
        • Department of Endocrinology, Coventry & Warwickshire Hospital
      • Leicester, United Kingdom, LE1 5WW
        • Department of Endocrinology, Leicester Royal Infirmary
      • Manchester, United Kingdom, M13 9WL
        • Department of Endocrinology, Manchester Royal Infirmary
      • Oxford, United Kingdom, OX3 7LJ
        • The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Department of Endocrinology, Royal Hallamshire Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Department of Endocrinology, Sunderland Royal Hospital
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
    • London
      • Hampstead, London, United Kingdom, NW3 2QG
        • Department of Endocrinology, The Royal Free 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:

  • The patient must have a clinical diagnosis of acromegaly
  • The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
  • The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
  • The patient must be able to store study medication in a refrigerator in their own home

Exclusion Criteria:

  • The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
  • The patient has received pituitary radiotherapy within one year prior to screening
  • The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
  • The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel

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: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.

Secondary Outcome Measures

Outcome Measure
To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
To assess patient/partner and healthcare professional experience with unsupervised injections.
To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.

Collaborators and Investigators

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

Sponsor

Ipsen

Investigators

  • Study Director: UK Medical Director, MD, 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

February 1, 2004

Primary Completion (Actual)

August 24, 2005

Study Completion (Actual)

August 24, 2005

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-97-52030-150

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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