Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis
Information source: Nordic Bioscience A/S
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Oral salmon calcitonin, salmon calcitonin nasal spray (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Nordic Bioscience A/S Official(s) and/or principal investigator(s):
Bente J Riis, M.D., Study Chair, Affiliation: Nordic Bioscience A/S
Summary
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma
calcitonin levels after administration of 0. 6 mg and 0. 8 mg oral calcitonin and 200 IU nasal
calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin
(0. 6 mg and 0. 8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and
CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral
calcitonin compared to placebo.
Clinical Details
Official title: SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Number of adverse events
Secondary outcome: Changes in Urine CTX-I and CTX-IIChanges in serum osteocalcin
Eligibility
Minimum age: 52 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Medical history and symptoms of knee osteoarthritis
Exclusion Criteria:
- Any other disease or medication affecting the bone or cartilage.
- Any clinical signs or laboratory evidence diseases, which in the Investigator's
opinion would preclude the participant from adhering to the Protocol or completing the
trial.
Locations and Contacts
CCBR a/S, Ballerup 2750, Denmark
Additional Information
Starting date: October 2005
Last updated: June 13, 2007
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