search
Back to results

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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lanreotide (Autogel formulation)
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: documentation of a diagnosis of active acromegaly based on either of the following definitions: 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 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

Sites / Locations

  • Baptist Health System Inc
  • Pituitary Center
  • Northwestern Medical Facility
  • Johns Hopkins University School of Medicine
  • Massachusetts General Hospital
  • University of Michigan Medical Center
  • New York University Medical Center
  • University of Cincinnati
  • Oregon Health Sciences University
  • University of Pennsylvania
  • Ben Taub Hospital
  • St Ann's Faculty Hospital
  • University Hospital Charles University
  • Charles University
  • Clinique Marc Linquette
  • Hôpital Lariboisière - Service de Médecine B
  • Hôpital Cochin - Service d'Endocrinologie
  • CHRU de Brabois
  • Universitätklinikum Charité
  • Med. Klinik der Universitätat Essen
  • Medizinische Klinik Innenstadt
  • Queen Mary Hospital
  • Semmelweiss University Medical School
  • Semmelweiss University
  • Academic Hospital Leiden
  • Academic Hospital Rotterdam
  • Queen Elizabeth Hospital
  • The Royal Free Hospital
  • Christie Hospital

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
October 6, 2005
Last Updated
August 1, 2019
Sponsor
Ipsen
search

1. Study Identification

Unique Protocol Identification Number
NCT00234572
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
January 3, 2003 (Actual)
Study Completion Date
January 3, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lanreotide (Autogel formulation)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: documentation of a diagnosis of active acromegaly based on either of the following definitions: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Health System Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Pituitary Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Northwestern Medical Facility
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Ben Taub Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St Ann's Faculty Hospital
City
Brno
Country
Czechia
Facility Name
University Hospital Charles University
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Charles University
City
Prague 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Clinique Marc Linquette
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Lariboisière - Service de Médecine B
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Cochin - Service d'Endocrinologie
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHRU de Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Universitätklinikum Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Med. Klinik der Universitätat Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Klinik Innenstadt
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Queen Mary Hospital
City
Pokfulam
Country
Hong Kong
Facility Name
Semmelweiss University Medical School
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Semmelweiss University
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Academic Hospital Leiden
City
Leiden
ZIP/Postal Code
2300
Country
Netherlands
Facility Name
Academic Hospital Rotterdam
City
Rotterdam
ZIP/Postal Code
3000
Country
Netherlands
Facility Name
Queen Elizabeth Hospital
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
The Royal Free Hospital
City
Hampstead
State/Province
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M204BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19639415
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs