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Sponsored by: |
Ipsen |
---|---|
Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00092287 |
The aim of this study is to compare the efficacy and safety of lanreotide Autogel and Sandostatin LAR Depot, to see whether these two 28-day prolonged release formulations produce a similar clinical response in patients with carcinoid syndrome.
Condition | Intervention | Phase |
---|---|---|
Malignant Carcinoid Syndrome |
Drug: lanreotide Autogel (somatostatin analogue) Drug: Sandostatin long acting release (LAR) Depot (somatostatin analogue) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III, Prospective, Multicenter, Randomized, Open, Parallel Group Comparison of Lanreotide Autogel® (90 and 120 mg) Administered by Deep Subcutaneous Injection Every Four Weeks, With Sandostatin LAR Depot (20 and 30 mg) Administered by Intramuscular Injection, Every Four Weeks for Six Months, in the Treatment of Clinical Symptoms Associated With Carcinoid Syndrome |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At the baseline visit patients MUST satisfy the following criteria before they are randomized to receive study treatment:
Exclusion Criteria:
Study ID Numbers: | 2-47-52030-722 |
Study First Received: | September 22, 2004 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00092287 |
Health Authority: | United States: Food and Drug Administration |
Carcinoid Syndrome Neuroendocrine Tumuors |
Serotonin Syndrome Poisoning Angiopeptin Octreotide 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, Hormonal Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists |
Cardiovascular Agents Hormones Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses |