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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00376064 |
Purpose
This study will investigate the efficacy of a combination treatment with octreotide acetate and cabergoline in acromegalic patients that are only partially responsive to a somatostatin analog monotherapy
| Condition | Intervention | Phase |
|---|---|---|
|
Acromegaly |
Drug: Octreotide acetate and cabergoline/Octrotide and Somavert |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | A Multicenter, Single Arm, Proof of Concept Study to Investigate the Efficacy of an 8 Month Combination Therapy of Octreotide and Cabergoline in Acromegalic Patients Only Partially Responsive to Somatostatin Analog Monotherapy |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| SMS995 + Carbegolin, Somavert + SMS995: Experimental | Drug: Octreotide acetate and cabergoline/Octrotide and Somavert |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| Contact: Novartis Pharmaceuticals | 800-340-6843 |
| Germany | |
| Novartis Investigative Site | Recruiting |
| Muenchen, Germany | |
| Novartis Investigative Site | Recruiting |
| Berlin, Germany | |
| Novartis Investigative Site | Recruiting |
| Essen, Germany | |
| Novartis Investigative Site | Recruiting |
| Erlangen, Germany | |
| Novartis Investigative Site | Recruiting |
| Tubingen, Germany | |
| Novartis Investigative Site | Recruiting |
| Koln, Germany | |
| Novartis Investigative Site | Recruiting |
| Leipzig, Germany | |
| Novartis Investigative Site | Recruiting |
| Wurzburg, Germany | |
| Novartis Investigative Site | Recruiting |
| Aachen, Germany | |
| Novartis Investigative Site | Recruiting |
| Marburg, Germany | |
| Novartis Investigative Site | Recruiting |
| Heidelberg, Germany | |
| Novartis Investigative Site | Recruiting |
| Bochum, Germany | |
| Novartis Investigative Site | Recruiting |
| Regensburg, Germany | |
| Novartis Investigative Site | Recruiting |
| Oldenburg, Germany | |
| Novartis Investigative Site | Recruiting |
| Greifswald, Germany | |
| Novartis Investigative Site | Recruiting |
| Ulm, Germany | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmeceuticals |
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CSMS995BDE16 |
| Study First Received: | September 13, 2006 |
| Last Updated: | November 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00376064 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Growth hormone (GH) IGF-1 Acromegaly Pituitary adenoma |
Brain tumor Brain cancer Octreotide acetate |
|
Pituitary Diseases Bone Diseases, Endocrine Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Anti-Dyskinesia Agents Physiological Effects of Drugs Octreotide Antiparkinson Agents Brain Diseases Dopamine Agonists Bone Diseases Hyperpituitarism |
Musculoskeletal Diseases Therapeutic Uses Acromegaly Hypothalamic Diseases Antineoplastic Agents, Hormonal Nervous System Diseases Gastrointestinal Agents Endocrine System Diseases Central Nervous System Diseases Pharmacologic Actions Dopamine Agents Cabergoline Central Nervous System Agents |