Skip to main content
OpenTrials
Completed

NCT Number: NCT00149188

Somatuline Autogel: Acromegaly Self/Partner Injection Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary, Hull, East Yorkshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanreotide (Autogel formulation)

Drug

Primary outcomes

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

Secondary outcomes

  1. To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.

  2. To assess patient/partner and healthcare professional experience with unsupervised injections.

  3. To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.