Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study) - Tabular View

Tracking Information

First Received Date ^ICMJE

June 24, 2008

Last Updated Date

April 22, 2009

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

• Joint Space Width in the medial tibio-femoral knee joint in the signal knee measured by X-ray change from baseline over 24 months • Pain to be assessed by the WOMAC pain sub score in the signal knee [ Time Frame: April 2011 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00704847 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• Bone & Cartilage metabolism biochemical marker change • Questionnaires to assess function, stiffness, pain, physical activity, and quality of life •Knee disease progression assessed by MRI [ Time Frame: April 2011 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Oral Salmon Calcitonin in Patients With Knee Osteoarthritis (OA 2 Study)

Official Title ^ICMJE

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis

Brief Summary

The purpose of this phase III study is to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Patients with Osteoarthritis of the Knee

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Drug: Oral Salmon Calcitonin
Drug: Oral Salmon Calcitonin (Placebo)

Study Arms / Comparison Groups

Active Comparator: SMC021 Oral Calcitonin
Placebo Comparator: SMC021 Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

920

Completion Date

Estimated Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Other protocol defined inclusion/exclusion criteria may apply

Gender

Both

Ages

51 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Czech Republic, Denmark, Hong Kong, Poland, Romania, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00704847

Responsible Party

Bente Juel Riis, Nordic Bioscience A/S

Study ID Numbers ^ICMJE

CSMC021C2302

Study Sponsor ^ICMJE

Nordic Bioscience A/S

Collaborators ^ICMJE

Novartis

Investigators ^ICMJE

Study Director:

Bente Juul Riis, MD

Nordic Bioscience

Information Provided By

Nordic Bioscience A/S

Verification Date

April 2009

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