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NCT00499993 Clinical Trial

Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Acromegaly Clinical Trial

Official title:
Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00499993
Other study ID # A-93-52030-077
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2001
Est. completion date May 2003

Study information
Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date May 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion Criteria:

- Patients who have undergone pituitary surgery less than 3 months before selection

- Patients previously treated with radiotherapy

- Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lanreotide (Autogel formulation), duration of treatment 46-48 weeks

Locations
Country Name City State
Italy Ospedali Riuniti di Bergamo Bergamo
Italy Ospedale Maggiore Bologna
Italy Clinica Medica - Sezione II Medicina Endocrinologia Brescia
Italy Università deglis Studi di Cagliari Cagliari
Italy Ospedale Garibaldi Catania
Italy Università degli Studi di Ferrara Ferrara
Italy Università degli Studi di Firenze Firenze
Italy D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche Genova
Italy Istituto Auxologico Milano
Italy Ospedale di Niguarda Cà Granda Milano
Italy Ospedale Maggiore IRCCS Milano
Italy Università "Federico II" di Napoli Napoli
Italy Ospedale "S. Luigi Gonzaga" Orbassano (TO)
Italy Università degli Studi di Padova Padova
Italy Azienda Ospedaliera "V. Cervello" Palermo
Italy Ospedale Cisanello Pisa
Italy Servizio di Endocrinologia Reggio Emilia
Italy Policlinico Agostino Gemelli Roma
Italy Università "La Sapienza" di Roma Roma
Italy Istituto di Patologia Speciale Medica e Metodologia Clinica Sassari
Italy Università degli Studi di Ancona, Ospedale Umberto I Sede Di Torrette (AN) Ancona
Italy Ospedale Molinette Torino
Italy Ospedale Cà Foncello Treviso
Italy Ospedale Santa Maria della Misericordia Udine

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatost — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Growth hormone assessment At every visit
Secondary Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments At every visit (with the exception of ALS at study inclusion)
Secondary Prolactin (PRL) assessment At study inclusion, visit 1 and at the final visit of the study
Secondary Lanreotide assessment At every visit
Secondary Clinical symptoms At every visit
Secondary Quality of life At visit 1 and at the final visit of the study
Secondary Tumour size At inclusion and at the final visit of the study
Secondary Evaluation of carotid vessels (on an optional basis) At inclusion and at the final visit of the study
Secondary Safety assessment evaluated by clinical data At every visit
Secondary Safety assessment evaluated by laboratory data At inclusion visit and at the final visit of the study
See also
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Completed NCT02012127 - Description of Sign-and-symptom Associations at Acromegaly Diagnosis.
Active, not recruiting NCT01265121 - Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism. N/A
Terminated NCT00765323 - Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly Phase 3
Completed NCT00500227 - Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following Surgery
Completed NCT00531908 - Physiopathology of Sodium Retention in Acromegaly N/A
Completed NCT01278342 - Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Phase 4
Active, not recruiting NCT01809808 - A Prospective Study of Outcome After Therapy for Acromegaly
Completed NCT00145405 - Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction Phase 4
Completed NCT00210457 - Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Phase 3
Recruiting NCT05401084 - Diet in the Management of Acromegaly N/A
Recruiting NCT00005100 - Measurement of Outcome of Surgical Treatment in Patients With Acromegaly N/A
Completed NCT00521300 - Preoperative Octreotide Treatment of Acromegaly Phase 4
Completed NCT03548415 - Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands Phase 2
Not yet recruiting NCT04066569 - Reproducibility and Utility of OGTT in Acromegaly N/A
Not yet recruiting NCT05298891 - Hypoproteic Diet in Acromegaly N/A
Recruiting NCT04520646 - A Pilot Study of Empagliflozin in the Treatment of Acromegalic Cardiomyopathy N/A
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3