Placebo controlled trial to evaluate the effect on pain and function of six months treatment doxycycline in established knee osteoarthritis - Doxy in Knee OA

Sint Maartenskliniek0 sites230 target enrollmentAugust 7, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•·Knee OA (index knee) according to the 1986 proposed ACR classification tree using clinical and radiological criteria (17\): knee pain (VAS \> 40mm during \> 50% of last month), the presence of osteophytes and one of the following: age \>50, crepitus, or morning stiffness \< 30 minutes.
•·Kellgren Lawrence score II or III
•·Criteria for mild to severe pain (KOOS pain sumscore question 5 to 9 \> 100 in the index knee) must be fulfilled
•·Ability to read and communicate well in Dutch.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

•·Other rheumatic diseases like rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematodes or psoriatic arthritis.
•·The presence of secondary OA including OA caused by orthopaedic problems (severe malalignment, trauma), ochronosis, acromegaly, calcium pyrophosphate deposition disease (CPPD), haemochromatosis.
•·Severe functional problems related to diseases other than OA (functional class ARA IV)
•·Cognitive deficits affecting the scoring processes.
•·Severe OA (Kellgren Lawrence score IV)
•·Ipsilateral hip prosthesis in situ.
•·Contraindications for doxycycline use like allergy for tetracyclines and prior adequate treatment with doxycycline (\>100mg for \> 6 weeks for OA).
•·Planned other major interventions within 24 weeks, including lower limb surgery and intensive multidisciplinary approaches.
•·Recent intra\-articular hyaluronic acid or corticosteroid application (\<3 months) or surgery (\<1 year) in the index knee.
•·Recent participation in other study (\< 3 months)