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Sponsors and Collaborators: |
Tercica Ipsen |
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Information provided by: | Tercica |
ClinicalTrials.gov Identifier: | NCT00774930 |
The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome.
Condition | Intervention | Phase |
---|---|---|
Carcinoid Syndrome |
Drug: lanreotide Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized Placebo-Controlled Clinical Trial Investigating the Efficacy and Safety of Somatuline Depot (Lanreotide) Injection in the Treatment of Carcinoid Syndrome |
Estimated Enrollment: | 100 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Somatuline Depot 120 mg
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Drug: lanreotide
subcutaneous injection, 120 mg, q28d
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2: Placebo Comparator
Placebo
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Drug: placebo
inactive substance
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rodney van Syoc | 650-238-1598 | rodney.vanSyoc@tercica.com |
Contact: Katrin Chondros | 650-238-1565 | katrin.chondros@tercica.com |
Study Chair: | Edda Gomez-Panzani, M.D. | Tercica |
Responsible Party: | Tercica ( Edda Gomez-Panzani, MD ) |
Study ID Numbers: | TR321 |
Study First Received: | October 15, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00774930 |
Health Authority: | United States: Food and Drug Administration |
carcinoid tumor |
Serotonin Syndrome Poisoning Angiopeptin Disorders of Environmental Origin Malignant Carcinoid Syndrome Carcinoid syndrome Somatostatin Neuroendocrine Tumors Carcinoma |
Carcinoid tumor Neuroectodermal Tumors Lanreotide Drug Toxicity Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Disease Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents |
Hormones Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses |