Who is sponsoring NCT00704847?

NCT00704847 is sponsored by Nordic Bioscience A/S.

What condition does NCT00704847 study?

NCT00704847 studies Osteoarthritis.

What drugs are being tested in NCT00704847?

Interventions: Oral Salmon Calcitonin, Oral Salmon Calcitonin (Placebo).

What is the status of NCT00704847?

NCT00704847 is currently TERMINATED.

Last reviewed 2019-04-03 · How we verify

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

NCT00704847 Phase 3 TERMINATED Results posted

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

Details

Lead sponsor	Nordic Bioscience A/S
Phase	Phase 3
Status	TERMINATED
Enrolment	1030
Start date	2008-06
Completion	2011-06

Conditions

Osteoarthritis

Interventions

Oral Salmon Calcitonin
Oral Salmon Calcitonin (Placebo)

Primary outcomes

Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months — Change from baseline to 24 months
The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24.
Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index — Change from baseline to 24 months
WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain).

Countries

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