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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001151-19-NL

Enrollment

230

Registered

2007-08-07

Start date

2007-08-21

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee, mild to severe pain MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis

Interventions

Product Name: doxycycline Pharmaceutical Form: Tablet INN or Proposed INN: DOXYCYCLINE MONOHYDRATE CAS Number: 17086281 Current Sponsor code: doxycycline Other descriptive name: doxycycline Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ·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 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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To asses the short term effect on pain and function and the safety of doxycycline in patients with mild to severe pain due to established knee OA.;Secondary Objective: ;Primary end point(s): Percentage of the patients achieving clinical response on pain and function, as defined by the OMERACT-OARSI set of responder criteria based on the KOOS dutch version (19) - pain (sumscore question 5 to 9) and function sumscore question 1-17 – and VAS patient Global Assessment at week 24 compared between placebo and verum	—

Measure

Time frame

Main Objective: To asses the short term effect on pain and function and the safety of doxycycline in patients with mild to severe pain due to established knee OA.;Secondary Objective: ;Primary end point(s): Percentage of the patients achieving clinical response on pain and function, as defined by the OMERACT-OARSI set of responder criteria based on the KOOS dutch version (19) - pain (sumscore question 5 to 9) and function sumscore question 1-17 – and VAS patient Global Assessment at week 24 compared between placebo and verum

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026