Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

NCT ID: NCT00216398

Last Updated: 2019-08-16

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-06-22

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Study Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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A-9B-52030-159

Identifier Type: -

Identifier Source: org_study_id

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