NL-OMON31361
Not yet recruiting
Phase 3
Placebo controlled trial to evaluate the effect on pain and function of six months treatment doxycycline in established knee osteoarthritis with an open extension up to two years - Symptomatic treatment with doxycycline in established knee osteoarthritis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sint Maartenskliniek
- Enrollment
- 230
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Knee OA (index knee) according to the 1986 proposed ACR classification tree using clinical and radiological criteria: 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.
Exclusion Criteria
- •· 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)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Placebo controlled trial to evaluate the effect on pain and function of six months treatment doxycycline in established knee osteoarthritis - Doxy in Knee OAOsteoarthritis of the knee, mild to severe painMedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritisEUCTR2007-001151-19-NLSint Maartenskliniek230
Not yet recruiting
Phase 3
Effect of homoeopathic medicine angustura vera in osteoarthritisCTRI/2022/05/042891Dr Girendra Pal Homoeopathic Hospital and Research Centre
Unknown
Not Applicable
ight to fight addictiochronic alcohol dependencyNL-OMON24477Technische Universiteit Eindhoven60
Completed
Not Applicable
A placebo-controlled trial to test the effectiveness of a lighting intervention to reduce or stabilize alcohol use and craving in alcohol dependent patientsNL-OMON49511Technische Universiteit Eindhoven60
Active, not recruiting
Not Applicable
Placebo-controlled trial investigating the effect of Vitamin K3-lotion for the treatment of cetuximab induced folliculitis - Vitamin K3EUCTR2009-016591-68-DKOdense University Hospital36