E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the knee joint |
|
MedDRA Classification |
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 identify the dose(s) of IDEA-033 that will provide a mimumum clinically meaningful effect for the treatment of signs and symptoms associated with osteoarthritis of the knee |
|
E.2.2 | Secondary objectives of the trial |
Comparissons of safety and efficacy of three doses of IDEA-033 to placebo.
This study will also determine if there is an increase in the therapeutic effect with increasing dose of IDEA-033 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Informed consent Age 18-75 Clinical diagnosis of osteoarthritis (OA) in at least one knee for a mimumum of 6 months Eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment. At baseline, subjects must have a WOMAC Pain subscale greater than or equal to 40mm, and at least 15mm greater than at the screeningvisit in the index knee Radiographic evidence of OA, as specified in the protocol ACR functional class I, II or III |
|
E.4 | Principal exclusion criteria |
Coagulopathy Pregnancy and lactation Skin lkesions or dermatological diseases in the tre4atment areas Any other investigational medicinal product within 90 days prior to screening Intra-articular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study Malignancy within the past 2 years History, physical examinations or radiographs suggestive of other rheumatic diseases Known hypersensitivity or contraindications to ketoprofen; NSAID idiosyncrasy History of peptic ulcers Severe liver or gastro-intestinal disease within the last 6 months History of clinically important renal, cardiovascula or neurological diseases Injections or change in oral treatment regimen of glucosamine, chondroitin sulphate, hyaluronic acid, shark cartilage, or Vitamin E within 3 months prior to screening Oral or parenteral corticosteroids within 3 months prior to screening Analgesic therapy for chronic or recurrent pain conditions for indications other than OA Immunosuppressants within 3 months of screening Concomitant medication interfering with ketoprofen or paracetamol, according to discretion of the Investigator |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline at Week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale Patient global assessment of response to therapy measured on a 5 point Likert Scale at Week 12 (or end of study measurements) Change from baseline at Week 12 (or end of study measurements) on the Visual Analogue Scale of the entire WOMAC Function |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |