Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery - Full Text View

Sponsor:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00500227

Purpose

The objective of this study is to evaluate, in acromegalic patients with disease persistence after surgery who are treated with somatostatin analogues, the histopathological, clinical, morphological and biochemical factors which are predictive of hormonal control.

Condition	Phase
Acromegaly	Phase IV

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study to Evaluate, in Acromegalic Patients With Disease Persistence After Surgery, Those Histopathologic, Clinical, Morphologic and Biochemical Factors Predictors of Hormonal Control Under Somatostatin Analogue Treatment

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Somatostatin

U.S. FDA Resources

Further study details as provided by Ipsen:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	55
Study Start Date:	September 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Acromegalic patients with persistence of the disease who attend specialized visits (Endocrinologist) at the Spanish hospitals.

Criteria

Inclusion Criteria:

Acromegalic patients with persistent disease (growth hormone ≥ 1ng/ml following oral glucose tolerance test and/or insulin like growth factor 1 above the normal range for sex and age) 3 to 6 months after transsphenoidal or transfrontal surgery

Exclusion Criteria:

Patients not contributing enough material for a tumour histopathological study
Patients who have received radiation therapy or will receive it during the observational study period
Patients who are being treated, or in whom treatment is anticipated, with either a dopaminergic agonist or a growth hormone receptor antagonist
Patients with a history of hypersensitivity to somatostatin analogues

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500227

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

Spain
Hospital "Miguel Servet"	Not yet recruiting
Zaragoza, Spain, 50009
Complejo Hospitalario de León. Hospital Virgen Blanca.	Not yet recruiting
Leon, Spain, 24071
Hospital Clínico Universitario de Santiago	Not yet recruiting
Santiago de Compostela, Spain, 15705
Hospital Clínico Universitario de Valencia	Not yet recruiting
Valencia, Spain, 46010
Hospital "Juan Canalejo"	Not yet recruiting
A Coruña, Spain, 15006
Hospital Clínico Universitario "Lozano Blesa"	Not yet recruiting
Zaragoza, Spain, 50009
Hospital "Marqués de Valdecilla"	Not yet recruiting
Santander, Spain, 39008
Hospital de Cruces	Not yet recruiting
Barakaldo, Spain, 48903
Hospital de La Princesa	Not yet recruiting
Madrid, Spain, 28006
Hospital Universitario Puerta de Hierro	Not yet recruiting
Madrid, Spain, 28035
Complexo Hospitalario de Orense	Not yet recruiting
Orense, Spain, 32005
Hospital Nuestra Señora de la Candelaria	Not yet recruiting
Santa Cruz de Tenerife, Spain, 38010
Complejo Hospitalario Xeral-Cies de Vigo	Recruiting
Vigo, Spain, 36204
Hospital Universitario de Getafe	Recruiting
Getafe, Spain, 28905
Hospital General Universitari d'Alacant	Recruiting
Alicante, Spain, 03012
Hospital Clínico de Madrid	Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario "12 de Octubre"	Not yet recruiting
Madrid, Spain, 28041
Hospital "Joan XXIII"	Not yet recruiting
Tarragona, Spain, 43007
Complejo Hospitalario Xeral-Calde de Lugo	Recruiting
Lugo, Spain, 27004
Hospital Clínico de Valladolid	Not yet recruiting
Valladolid, Spain, 47005
Hospital Universitario "La Paz"	Recruiting
Madrid, Spain, 28046
Hospital "Mútua de Terrassa"	Not yet recruiting
Barcelona, Spain, 08221
Hospital "Son Dureta"	Not yet recruiting
Palma de Mallorca, Spain, 07014
Hospital Clínic i Provincial de Barcelona	Not yet recruiting
Barcelona, Spain, 08036
Hospital General de la Vall d´Hebron	Recruiting
Barcelona, Spain, 08035
Fundación Jiménez Díaz	Not yet recruiting
Madrid, Spain, 28040
Hospital "Ramón y Cajal"	Not yet recruiting
Madrid, Spain, 28034
Hospital Prínceps d'Espanya	Recruiting
Barcelona, Spain, 08907
Hospital de la Santa Creu i Sant Pau	Recruiting
Barcelona, Spain, 08025
Hospital de Navarra	Not yet recruiting
Pamplona, Spain, 31008

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Eva Pineda, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Eva Pineda )
Study ID Numbers:	A-92-52030-728
Study First Received:	July 11, 2007
Last Updated:	January 19, 2010
ClinicalTrials.gov Identifier:	NCT00500227 History of Changes
Health Authority:	Spain: Ministry of Health

Additional relevant MeSH terms:

Pituitary Diseases
Bone Diseases, Endocrine
Hypothalamic Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Diseases
Endocrine System Diseases

Brain Diseases
Bone Diseases
Hormones
Pharmacologic Actions
Somatostatin
Hyperpituitarism
Musculoskeletal Diseases
Acromegaly

ClinicalTrials.gov processed this record on February 08, 2010