Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234572

Enrollment

108

Registered

2005-10-07

Start date

2000-05-31

Completion date

2003-01-03

Last updated

2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Interventions

DRUGLanreotide (Autogel formulation)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* documentation of a diagnosis of active acromegaly based on either of the following definitions: 1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level \>5ng/mL at visit 1; or 2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH \>3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)

Exclusion criteria

* receipt of radiotherapy for acromegaly within 3 years * pituitary surgery within 3 months prior to visit 1 * prior receipt of lanreotide autogel or GH antagonist * anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period * known hypersensitivity to any of the test materials or related compounds * clinically significant renal or hepatic abnormalities

Design outcomes

Primary

Measure	Time frame
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal	—

Secondary

Measure	Time frame
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal	—

Countries

Czechia, France, Germany, Hong Kong, Hungary, Netherlands, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026