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Sponsored by: |
Unigene Laboratories Inc. |
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Information provided by: | Unigene Laboratories Inc. |
ClinicalTrials.gov Identifier: | NCT00620854 |
This study compares the performance of different doses of oral salmon calcitonin.
Condition | Intervention | Phase |
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Osteoporosis |
Drug: Recombinant Salmon Calcitonin |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Enrollment: | 24 |
Study Start Date: | February 2008 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Recombinant Salmon Calcitonin
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
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Ages Eligible for Study: | 45 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Missouri | |
Bio-Kinetic Clinical Applications, Inc. | |
Springfield, Missouri, United States, 65802 |
Principal Investigator: | Thomas Legg, D.O. | Bio-Kinetic Clinical Applications, Inc. |
Responsible Party: | Unigene Laboratories, Inc. ( Dr. Kristine A. Erickson, Senior Director of Clinical Affairs ) |
Study ID Numbers: | UGL-OR0702, Bio-Kinetic No.:96508 |
Study First Received: | February 12, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00620854 |
Health Authority: | United States: Food and Drug Administration |
Calcitonin Gene-Related Peptide Calcitonin Musculoskeletal Diseases Osteoporosis |
Bone Diseases, Metabolic Healthy Salmon calcitonin Bone Diseases |
Vasodilator Agents Therapeutic Uses Physiological Effects of Drugs |
Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |