E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the knee, mild to severe pain |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 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. |
|
E.4 | Principal 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) |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
the last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |