Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00690898

Purpose

Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and IGF-1 levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.

Condition	Intervention	Phase
Acromegaly	Drug: Lanreotide autogel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

The primary efficacy endpoint will be the percentage of patients achieving reduction in tumor volume at V5 (at Week 48) in comparison to baseline (as measured by MRI) [ Time Frame: From W1 (baseline) to W48. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of serum IGF-1 level and serum GH levels [ Time Frame: At W1, 12, 24 & 48 ] [ Designated as safety issue: No ]
Changes of prolactin level in patients with initially increased prolactin level (at screening) [ Time Frame: At each assessment (W12, 24 & 48). ] [ Designated as safety issue: No ]
Change of clinical signs of acromegaly [ Time Frame: At each assessment visit at W12,24 &48 ] [ Designated as safety issue: No ]
Changes in the quality of life assessment [ Time Frame: At each assessment visit at W12, 24 & 48 ] [ Designated as safety issue: No ]
Adverse events and local tolerability information [ Time Frame: Recorded at any time during the study ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Recorded at each assessment ] [ Designated as safety issue: Yes ]
Physical examination findings [ Time Frame: Recorded at each assessment ] [ Designated as safety issue: Yes ]
Gallbladder ultrasound [ Time Frame: Assessed at screening and W48 ] [ Designated as safety issue: Yes ]
Laboratory tests: standard haematology and biochemistry analyses [ Time Frame: At W1 and W48 ] [ Designated as safety issue: Yes ]
Glucose tolerance based on fasting blood glucose [ Time Frame: At W12, 24 & 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lanreotide autogel	Drug: Lanreotide autogel 12 months

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has given written informed consent prior to any study related procedures.
The patient is male or female and is aged between 18 and 75 years, inclusive
Diagnosis of acromegaly defined by increased GH level and IGF-1. concentrations elevated above the age- and sex-matched normal range.
The patient has a pituitary adenoma with a diameter of more or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading.

Exclusion Criteria:

The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry.
The patient has previously been treated with a somatostatin analogue.
The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry.
Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690898

Contacts

Contact: Ipsen Recruitment Enquiries

Clinical.trials@ipsen.com

Locations

Belgium
University Hospital Antwerp	Recruiting
Antwerpen, Belgium, B2650
Czech Republic
Všeobecná fakultní nemocnice, Karlova Univerzita	Recruiting
Praha, Czech Republic, 128 08 Praha 2
Finland
Helsinki University Center Hospital	Recruiting
Helsinki, Finland, 9 FIN-00290
The Turku University Central Hospital	Recruiting
Turku, Finland, SF-20521
France
CHU Henri Mondor	Recruiting
Créteil, France, 94000
Hôpital Claude Huriez	Recruiting
Lille, France, 59037 Cedex
Groupement Hospitalier Est	Recruiting
Lyon, France, 69677 Bron Cedex
Hôpital de la Timone	Recruiting
Marseille, France, 13385
Hôpital Bicêtre	Recruiting
Paris, France, 94275 Cedex
Hôpital Maison Blanche	Recruiting
Reims, France, 51092 Cedex
Hopital Larrey	Recruiting
Toulouse, France, 31059
Germany
Klinikum der Johann Wolfgang Goethe-Universität	Recruiting
Frankfurt, Germany, 60590
Universitatsklinikum Essen	Recruiting
Essen, Germany, 45122
Friedrich-Alexander University	Recruiting
Erlangen, Germany, 91054
Medizinische Klinik Innenstadt	Recruiting
München, Germany, 80336
Italy
AOU Policlinico "G. Martino" Messina	Recruiting
Messina, Italy, 98125
Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia	Recruiting
Napoli, Italy, 5 80131
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia	Recruiting
Roma, Italy, 00161
Netherlands
UMC Leiden	Recruiting
Leiden, Netherlands, 2333
UMC Utrecht	Recruiting
Utrecht, Netherlands, 3501
Spain
Hospital Virgen del Rocío	Recruiting
Sevilla, Spain, 41013
Sweden
University Hospital	Recruiting
Lund, Sweden, 221 85
University Hospital, Lund	Recruiting
Stockholm, Sweden, 17176
Turkey
Cerrahpasa Medical Facility	Recruiting
Istanbul, Turkey, 34303
United Kingdom
27/28 Aberdeen Royal Infirmary	Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Derriford Hospital	Recruiting
Plymouth, United Kingdom, PL6 8DH
Christie Hospital	Recruiting
Manchester, United Kingdom, M20 4BX
Queen Elizabeth Hospital	Recruiting
Birmingham, United Kingdom, B15 2TH

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Antoine Clermont, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Antoine Clermont )
Study ID Numbers:	2-79-52030-207
Study First Received:	June 3, 2008
Last Updated:	September 29, 2009
ClinicalTrials.gov Identifier:	NCT00690898 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Germany: Ministry of Health; Sweden: Medical Products Agency; Czech Republic: State Institute for Drug Control; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Finland: Finnish Medicines Agency; Turkey: Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Ministry of Health; Switzerland: Swissmedic

Additional relevant MeSH terms:

Pituitary Diseases
Bone Diseases, Endocrine
Hypothalamic Diseases
Antineoplastic Agents
Nervous System Diseases
Central Nervous System Diseases
Endocrine System Diseases
Angiopeptin
Cardiovascular Agents

Brain Diseases
Bone Diseases
Pharmacologic Actions
Lanreotide
Hyperpituitarism
Musculoskeletal Diseases
Therapeutic Uses
Acromegaly

ClinicalTrials.gov processed this record on November 20, 2009