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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486369
First Posted: June 14, 2007
Last Update Posted: June 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Nordic Bioscience A/S
  Purpose
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.

Condition Intervention Phase
Osteoarthritis Drug: Oral salmon calcitonin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.

Resource links provided by NLM:


Further study details as provided by Nordic Bioscience A/S:

Secondary Outcome Measures:
  • Changes in Urine CTX-I and CTX-II
  • Changes in serum osteocalcin and serum CTX-I
  • Number of adverse events

Study Start Date: January 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486369


Locations
Denmark
CCBR A/S
Ballerup, Denmark, 2750
Sponsors and Collaborators
Nordic Bioscience A/S
Novartis
Investigators
Study Chair: Bente J Riis, M.D. Nordic Bioscience A/S
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00486369     History of Changes
Other Study ID Numbers: CSMC021C2102
First Submitted: June 13, 2007
First Posted: June 14, 2007
Last Update Posted: June 14, 2007
Last Verified: June 2007

Keywords provided by Nordic Bioscience A/S:
Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Bone Density Conservation Agents
Physiological Effects of Drugs
Vasodilator Agents