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Sponsored by: |
Endo Pharmaceuticals Solutions Inc. |
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Information provided by: | Endo Pharmaceuticals Solutions Inc. |
ClinicalTrials.gov Identifier: | NCT00884715 |
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
Condition | Intervention | Phase |
---|---|---|
Carcinoid Syndrome |
Drug: octreotide acetate Drug: octreotide implant |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Pharmacokinetics Study |
Official Title: | Open Label, Randomized Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome |
Estimated Enrollment: | 20 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 implant: Experimental
117 mg implant
|
Drug: octreotide acetate
one or two 117 mg octreotide implants
Drug: octreotide implant
117 mg 234 mg
|
2 implants: Experimental
234 mg
|
Drug: octreotide acetate
one or two 117 mg octreotide implants
Drug: octreotide implant
117 mg 234 mg
|
This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 6 months.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Roessel | roessel.mark@endo.com |
United States, Massachusetts | |
Burlington, Massachusetts, United States, 01805 |
Responsible Party: | Lahey Clinic ( Keith Stuart ) |
Study ID Numbers: | IP107-002 |
Study First Received: | April 20, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00884715 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Carcinoid Syndrome Antineoplastic Agents, Hormonal Serotonin Syndrome Poisoning Octreotide Disorders of Environmental Origin Malignant Carcinoid Syndrome Neuroendocrine Tumors |
Carcinoma Neuroectodermal Tumors Drug Toxicity Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor Adenocarcinoma Neoplasms, Glandular and Epithelial |
Disease Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Neoplasms, Nerve Tissue Gastrointestinal Agents Poisoning Serotonin Syndrome Octreotide Disorders of Environmental Origin Malignant Carcinoid Syndrome Pharmacologic Actions |
Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Neoplasms Pathologic Processes Drug Toxicity Therapeutic Uses Syndrome Neoplasms, Germ Cell and Embryonal Carcinoid Tumor Adenocarcinoma Neoplasms, Glandular and Epithelial |