Somatuline Autogel: Acromegaly Self/Partner Injection Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-08-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lanreotide (Autogel formulation)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No