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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Nordic Bioscience A/S
ClinicalTrials.gov Identifier:
NCT00486369
First received: June 13, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 13, 2007
June 13, 2007
January 2007
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No Changes Posted
  • Changes in Urine CTX-I and CTX-II
  • Changes in serum osteocalcin and serum CTX-I
  • Number of adverse events
Same as current
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SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Osteoarthritis
Drug: Oral salmon calcitonin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
52 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00486369
CSMC021C2102
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Nordic Bioscience A/S
Novartis
Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
Nordic Bioscience A/S
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP