Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects (LEAD)

Ipsen

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: Lanreotide Autogel 120 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00701363

2007-005838-37 (EudraCT Number)

A-38-52030-214

Details and patient eligibility

About

The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject has given written informed consent prior to any study-related procedures
• The subject is male or female and is over 18 years of age
• The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF-1 and/or GH levels
• The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF 1 levels for two consecutive measurements (at least two months apart) preceding study entry
• If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period

Exclusion criteria

• The subject has received radiation therapy to the pituitary gland before study entry
• The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
• The subject has received a growth hormone receptor antagonist (pegvisomant) therapy within three months before study entry
• The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than lanreotide 120 mg, during the course of the study
• The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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124 participants in 1 patient group

Lanreotide Autogel 120 mg

Experimental group

Treatment:

Drug: Lanreotide Autogel 120 mg