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Sponsors and Collaborators: |
Université Catholique de Louvain Novartis |
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Information provided by: | Université Catholique de Louvain |
ClinicalTrials.gov Identifier: | NCT00376311 |
To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis
Condition | Intervention | Phase |
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Osteoarthritis |
Drug: oral salmon calcitonin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis |
Estimated Enrollment: | 54 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | May 2004 |
Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.
Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.
Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain | |
Brussels, Belgium, B-1200 |
Study Director: | Daniel H Manicourt, MD, PhD | Department of Rheumatology, University hospital St Luc, Brussels, Belgium |
Study ID Numbers: | Daniel H Manicourt |
Study First Received: | December 30, 2005 |
Last Updated: | September 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00376311 |
Health Authority: | Belgium: Institutional Review Board |
Lequesne's algo-functional score Biomarkers of joint metabolism |
Calcitonin Gene-Related Peptide Calcitonin Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases Salmon calcitonin |
Vasodilator Agents Therapeutic Uses Physiological Effects of Drugs |
Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |