Clinical trial NCT00234572: Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Health System Inc
state: Alabama
city: Los Angeles
country: United States
facility: Pituitary Center
state: California
city: Chicago
country: United States
facility: Northwestern Medical Facility
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
city: Brno
country: Czechia
facility: St Ann's Faculty Hospital
city: Hradec Kralove
country: Czechia
facility: University Hospital Charles University
city: Prague 2
country: Czechia
facility: Charles University
city: Lille
country: France
facility: Clinique Marc Linquette
city: Paris
country: France
facility: Hôpital Lariboisière - Service de Médecine B
city: Paris
country: France
facility: Hôpital Cochin - Service d'Endocrinologie
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU de Brabois
city: Berlin
country: Germany
facility: Universitätklinikum Charité
city: Essen
country: Germany
facility: Med. Klinik der Universitätat Essen
city: Munchen
country: Germany
facility: Medizinische Klinik Innenstadt
city: Pokfulam
country: Hong Kong
facility: Queen Mary Hospital
city: Budapest
country: Hungary
facility: Semmelweiss University Medical School
city: Budapest
country: Hungary
facility: Semmelweiss University
city: Leiden
country: Netherlands
facility: Academic Hospital Leiden
city: Rotterdam
country: Netherlands
facility: Academic Hospital Rotterdam
city: Edgbaston
country: United Kingdom
facility: Queen Elizabeth Hospital
state: Birmingham
city: Hampstead
country: United Kingdom
facility: The Royal Free Hospital
state: London
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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 study with a 52 week open extension. Pituitary. 2010;13(1):18-28. doi: 10.1007/s11102-009-0191-1. Epub 2009 Jul 29.