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NCT00486369 Clinical Trial

SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study

Osteoarthritis Clinical Trial

Official title:
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00486369
Other study ID # CSMC021C2102
Secondary ID
Status Completed
Phase Phase 1
First received June 13, 2007
Last updated June 13, 2007
Start date January 2007

Study information
Verified date June 2007
Source Nordic Bioscience A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 52 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oral salmon calcitonin

Locations
Country Name City State
Denmark CCBR A/S Ballerup

Sponsors (2)
Lead Sponsor Collaborator
Nordic Bioscience A/S Novartis

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Secondary Changes in Urine CTX-I and CTX-II
Secondary Changes in serum osteocalcin and serum CTX-I
Secondary Number of adverse events
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