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

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00234572
Collaborator
(none)
108
Enrollment
29
Locations
32.1
Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lanreotide (Autogel formulation)
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date :
May 1, 2000
Actual Primary Completion Date :
Jan 3, 2003
Actual Study Completion Date :
Jan 3, 2003

Outcome Measures

Primary Outcome Measures

  1. 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Health System Inc Birmingham Alabama United States 35213
2 Pituitary Center Los Angeles California United States 90048
3 Northwestern Medical Facility Chicago Illinois United States 60611
4 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
5 Massachusetts General Hospital Boston Massachusetts United States 02114
6 University of Michigan Medical Center Ann Arbor Michigan United States 48109
7 New York University Medical Center New York New York United States 10010
8 University of Cincinnati Cincinnati Ohio United States 45267
9 Oregon Health Sciences University Portland Oregon United States 97201
10 University of Pennsylvania Philadelphia Pennsylvania United States 19104
11 Ben Taub Hospital Houston Texas United States 77030
12 St Ann's Faculty Hospital Brno Czechia
13 University Hospital Charles University Hradec Kralove Czechia 500 05
14 Charles University Prague 2 Czechia 120 00
15 Clinique Marc Linquette Lille France 59037
16 Hôpital Lariboisière - Service de Médecine B Paris France 75010
17 Hôpital Cochin - Service d'Endocrinologie Paris France 75014
18 CHRU de Brabois Vandoeuvre-les-Nancy France 54511
19 Universitätklinikum Charité Berlin Germany 10117
20 Med. Klinik der Universitätat Essen Essen Germany 45147
21 Medizinische Klinik Innenstadt Munchen Germany 80336
22 Queen Mary Hospital Pokfulam Hong Kong
23 Semmelweiss University Medical School Budapest Hungary 1088
24 Semmelweiss University Budapest Hungary 1135
25 Academic Hospital Leiden Leiden Netherlands 2300
26 Academic Hospital Rotterdam Rotterdam Netherlands 3000
27 Queen Elizabeth Hospital Edgbaston Birmingham United Kingdom B15 2TH
28 The Royal Free Hospital Hampstead London United Kingdom NW3 2QG
29 Christie Hospital Manchester United Kingdom M204BX

Sponsors and Collaborators

  • Ipsen

Investigators

  • Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT00234572
Other Study ID Numbers:
  • E-28-52030-717
First Posted:
Oct 7, 2005
Last Update Posted:
Aug 2, 2019
Last Verified:
Aug 1, 2019
Additional relevant MeSH terms:
Acromegaly
Lanreotide

Study Results

No Results Posted as of Aug 2, 2019