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| Sponsor: | Ipsen |
|---|---|
| Information provided by: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00383708 |
Purpose
The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: lanreotide (Autogel formulation) Drug: Pegvisomant |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone |
| Enrollment: | 125 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: lanreotide (Autogel formulation)
120 mg administered via deep subcutaneous injection every 28 days over 28 weeks.
Drug: Pegvisomant
Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| Charles University | |
| Prague, Czech Republic, 120 00 PRAHA 2 | |
| University Hospital, Charles University | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Denmark | |
| Aarhus Kommunehospital | |
| Aarhus, Denmark | |
| France | |
| Clinique Marc Linquette | |
| Lille Cedex, France, 59037 | |
| CHU de Rangueil | |
| Toulouse, France, 31054 | |
| Hôpital Bicêtre | |
| Le Kremlin-Bicêtre, France, 94275 | |
| Hôpital de la Timone | |
| Marseille Cedex, France, 13385 | |
| Groupe Hospitalier Henri Mondor- Albert Chenevier | |
| Créteil Cedex, France | |
| Germany | |
| Charite Campus Mitte | |
| Berlin, Germany, 10117 | |
| Medizinische Klinik Innenstadt | |
| Munchen, Germany, 80336 | |
| Klinikum Johann Wolfgang Goethe-Universität | |
| Frankfurt, Germany, 605090 | |
| Greece | |
| Anticancer Hospital Metaxa Piraeus | |
| Piraeus, Greece, 18537 | |
| Italy | |
| Universitá di Torino | |
| Torino, Italy, 10126 | |
| Universitá degli Studi di Milano | |
| Milano, Italy, 20122 | |
| University Federico II | |
| Napoli, Italy, 80131 | |
| Netherlands | |
| Dept. of Internal Medicine Erasmus MC | |
| Rotterdam, Netherlands, 3015 GD | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Spain | |
| Hospital General de Alicante | |
| Alicante, Spain, 03012 | |
| Hospital Clínico Universitario de Santiago de Compostela | |
| Santiago de Compostela, Spain, 15706 | |
| Clínica Puerta de Hierro | |
| Madrid, Spain, 28035 | |
| Sweden | |
| Sahlgrenska University Hospital | |
| Göteborg, Sweden, 413 45 | |
| Uppsala University Hospital | |
| Uppsala, Sweden, 75185 | |
| United Kingdom | |
| Christie Hospital and Holt Radium Institute | |
| Manchester, United Kingdom, M20 4BX | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom | |
| Study Director: | Pascal Birman, MD | Ipsen |
More Information
| Responsible Party: | Ipsen ( Dr Pascal Birman ) |
| Study ID Numbers: | 2-55-52030-727 |
| Study First Received: | October 2, 2006 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00383708 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Italy: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; Greece: National Organization of Medicines; Czech Republic: State Institute for Drug Control |
|
Bone Diseases, Endocrine Hypothalamic Diseases Pituitary 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 |