Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00499993
First received: July 11, 2007
Last updated: December 21, 2009
Last verified: December 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: lanreotide (Autogel formulation), duration of treatment 46-48 weeks |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Growth hormone assessment [ Time Frame: At every visit ]
Secondary Outcome Measures:
- Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments [ Time Frame: At every visit (with the exception of ALS at study inclusion) ]
- Prolactin (PRL) assessment [ Time Frame: At study inclusion, visit 1 and at the final visit of the study ]
- Lanreotide assessment [ Time Frame: At every visit ]
- Clinical symptoms [ Time Frame: At every visit ]
- Quality of life [ Time Frame: At visit 1 and at the final visit of the study ]
- Tumour size [ Time Frame: At inclusion and at the final visit of the study ]
- Evaluation of carotid vessels (on an optional basis) [ Time Frame: At inclusion and at the final visit of the study ]
- Safety assessment evaluated by clinical data [ Time Frame: At every visit ]
- Safety assessment evaluated by laboratory data [ Time Frame: At inclusion visit and at the final visit of the study ]
| Enrollment: | 63 |
| Study Start Date: | January 2001 |
| Study Completion Date: | May 2003 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499993
Locations
| Italy | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24128 | |
| Ospedale Maggiore | |
| Bologna, Italy, 40133 | |
| Clinica Medica - Sezione II Medicina Endocrinologia | |
| Brescia, Italy, 25125 | |
| Università deglis Studi di Cagliari | |
| Cagliari, Italy, 09124 | |
| Ospedale Garibaldi | |
| Catania, Italy, 95123 | |
| Università degli Studi di Ferrara | |
| Ferrara, Italy, 44100 | |
| Università degli Studi di Firenze | |
| Firenze, Italy, 50134 | |
| D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche | |
| Genova, Italy, 16100 | |
| Istituto Auxologico | |
| Milano, Italy, 20100 | |
| Ospedale Maggiore IRCCS | |
| Milano, Italy, 20122 | |
| Ospedale di Niguarda Cà Granda | |
| Milano, Italy, 20162 | |
| Università "Federico II" di Napoli | |
| Napoli, Italy, 80131 | |
| Ospedale "S. Luigi Gonzaga" | |
| Orbassano (to), Italy, 10043 | |
| Università degli Studi di Padova | |
| Padova, Italy, 35128 | |
| Azienda Ospedaliera "V. Cervello" | |
| Palermo, Italy, 90148 | |
| Ospedale Cisanello | |
| Pisa, Italy, 56100 | |
| Servizio di Endocrinologia | |
| Reggio Emilia, Italy, 42100 | |
| Università "La Sapienza" di Roma | |
| Roma, Italy, 00161 | |
| Policlinico Agostino Gemelli | |
| Roma, Italy, 00168 | |
| Istituto di Patologia Speciale Medica e Metodologia Clinica | |
| Sassari, Italy, 07199 | |
| Università degli Studi di Ancona, Ospedale Umberto I | |
| Sede Di Torrette (an) Ancona, Italy, 60020 | |
| Ospedale Molinette | |
| Torino, Italy, 10126 | |
| Ospedale Cà Foncello | |
| Treviso, Italy, 31100 | |
| Ospedale Santa Maria della Misericordia | |
| Udine, Italy, 33100 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Paolo Boscani, MD | Ipsen |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00499993 History of Changes |
| Other Study ID Numbers: | A-93-52030-077 |
| Study First Received: | July 11, 2007 |
| Last Updated: | December 21, 2009 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Endocrine System Diseases Lanreotide Angiopeptin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013