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Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

Phase 3
18 Years
75 Years
Not Enrolling

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Trial Information

Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

Inclusion Criteria:

- The patient has given written informed consent prior to any study related procedures

- The patient is male or female and is aged between 18 and 75 years, inclusive,

- Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral
glucose tolerance test for non diabetic patients (central laboratory results) or a
mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic
patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above
the age- and sex-matched normal range for diabetic and non diabetic patients (central
laboratory results),

- The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm
based on Magnetic Resonance Imaging (MRI) central reading,

- The patient has no visual field defect identified at the visual evaluation, performed
by Goldman Visual Fields Analyser and Automated visual field static perimeter, except
visual field abnormality at the time of screening and that is in the investigator's
Clinical judgement:

- Not related to the pituitary adenoma

- Clinically stable condition not presumed to change during the study period

- Not modifying the ability to evaluate visual field changes related to the

Exclusion Criteria:

- The patient has a history of hypersensitivity to Lanreotide or drugs with a similar
chemical structure,

- The patient has received any unlicensed drug within the 30 days prior to the
screening visit or is scheduled to receive an unlicensed drug during the course of
the study,

- The patient is likely to require treatment during the study with somatostatin
analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor
antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the
study protocol,

- The patient is a female at risk of pregnancy during the study and is not using
acceptable contraceptive methods. Females of childbearing potential must provide a
negative pregnancy test at start of study and must be using oral, double barrier
(condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide;
or male condom and diaphragm with spermicide), injectable contraception or an intra
uterine device. Non childbearing potential is defined as post-menopause for at least
1 year, surgical sterilisation or hysterectomy at least three months before the start
of the study,

- The patient is pregnant or lactating,

- The patient has a history of, or known current, problems with alcohol abuse,

- The patient has any mental condition rendering the patient unable to understand the
nature, scope and possible consequences of the study, and/or evidence of an
uncooperative attitude.

- The patient has abnormal baseline findings, any other medical condition(s) or
laboratory findings that, in the opinion of the Investigator, might jeopardize the
patient's safety or decrease the chance of obtaining satisfactory data needed to
achieve the objective(s) of the study,

- The patient has undergone pituitary surgery or pituitary radiotherapy prior to study

- The patient has previously been treated with a somatostatin analogue,

- The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant)
prior to study entry,

- The patient is expected to require pituitary surgery (adenomectomy) or to receive
radiotherapy during the study period,

- Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL (central
laboratory results),

- Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe
renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2),

- Patient known by Investigator, to have congenital or acquired optic nerve disease or
any visual abnormality with risk of worsening during the course of the study (e.g
glaucoma), influencing ability to evaluate Visual Field changes related to the

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint will be the percentage of patients achieving reduction in tumor volume at V5 (at Week 48) in comparison to baseline (as measured by MRI)

Outcome Time Frame:

From W1 (baseline) to W48.

Safety Issue:


Principal Investigator

Antoine Clermont, MD

Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

May 2008

Completion Date:

February 2012

Related Keywords:

  • Acromegaly
  • Acromegaly