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NCT00234572 Clinical Trial

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

Acromegaly Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00234572
Other study ID # E-28-52030-717
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 2000
Est. completion date January 3, 2003

Study information
Verified date August 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date January 3, 2003
Est. primary completion date January 3, 2003
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lanreotide (Autogel formulation)

Locations
Country Name City State
Czechia St Ann's Faculty Hospital Brno
Czechia University Hospital Charles University Hradec Kralove
Czechia Charles University Prague 2
France Clinique Marc Linquette Lille
France Hôpital Cochin - Service d'Endocrinologie Paris
France Hôpital Lariboisière - Service de Médecine B Paris
France CHRU de Brabois Vandoeuvre-les-Nancy
Germany Universitätklinikum Charité Berlin
Germany Med. Klinik der Universitätat Essen Essen
Germany Medizinische Klinik Innenstadt Munchen
Hong Kong Queen Mary Hospital Pokfulam
Hungary Semmelweiss University Budapest
Hungary Semmelweiss University Medical School Budapest
Netherlands Academic Hospital Leiden Leiden
Netherlands Academic Hospital Rotterdam Rotterdam
United Kingdom Queen Elizabeth Hospital Edgbaston Birmingham
United Kingdom The Royal Free Hospital Hampstead London
United Kingdom Christie Hospital Manchester
United States University of Michigan Medical Center Ann Arbor Michigan
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Baptist Health System Inc Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern Medical Facility Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Ben Taub Hospital Houston Texas
United States Pituitary Center Los Angeles California
United States New York University Medical Center New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States Oregon Health Sciences University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

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

References & Publications (1)

Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
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Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
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Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3