Current partner codePEPTIDESDE
NCT00149188·Phase 4·INTERVENTIONAL

Somatuline Autogel: Acromegaly Self/Partner Injection Study

Status

Completed

Phase

Phase 4

Enrollment

30

Locations

10

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Lanreotide (Autogel formulation)

Timeline

From registration to results.

  1. First posted

    Sep 8, 2005

  2. Study start

    Feb 2004

  3. Primary completion

    Aug 24, 2005

  4. Study completion

    Aug 24, 2005

  5. Results posted

    Not reported

  6. Registry updated

    Aug 5, 2019

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

10 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary

Hull, East Yorkshire, United Kingdom

Department of Endocrinology, The Royal Free Hospital

Hampstead, London, United Kingdom

Dept of Endocrinology, Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Department of Medicine, Queen Elizabeth Hospital

Birmingham, United Kingdom

Department of Endocrinology, Coventry & Warwickshire Hospital

Coventry, United Kingdom

Department of Endocrinology, Leicester Royal Infirmary

Leicester, United Kingdom

Department of Endocrinology, Manchester Royal Infirmary

Manchester, United Kingdom

The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital

Oxford, United Kingdom

Department of Endocrinology, Royal Hallamshire Hospital

Sheffield, United Kingdom

Department of Endocrinology, Sunderland Royal Hospital

Sunderland, United Kingdom

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

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