| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Symptomatic treatment for pain and inflammation associated with irritations of degenerative joint diseases, e.g. ostheoarthitis of the hip, knee or fingers |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10031161 |
|
| 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 |
The aim of this study is the comparison of the effects of treatment with three different oral formulations of diclofenac with regard to tolerability and efficacy in patients with painful condition of osteoarthritis.
Primary objectives: Comparison of Diclo 150 HEXAL vs. Voltaren® Dispers
Safety:
- incidence of all drug related gastrointestinal adverse events
- incidence of all drug related adverse events
Efficacy:
- change of patient's overall assessment of pain in the target
joint (global pain) from baseline to Visit 4 (week 2, VAS)
|
|
| E.2.2 | Secondary objectives of the trial |
Safety
incidence and intensity of all adverse events
incidence and intensity of all gastrointestinal adverse events
intensity of all drug related adverse events
intensity of all drug related gastrointestinal adverse events
incidence and intensity of serious adverse events
comparison of the overall symptom load of all drug related and gastro- intestinal adverse events for patients with at least one drug related adverse event
compliance adjusted adverse event rates
comparison of the compliance weighted overall symptom load of all drug related (gastrointestinal) adverse events for patients with at least one drug related adverse event
withdrawal due to drug related adverse events
withdrawal due to gastrointestinal adverse events which require treatment
overall tolerability assessed by patient/physician
Efficacy
change in patients overall assessment of pain in the target joint (global pain)
response rate
overall efficacy change in WOMAC® / Dreiser index
general wellbeing |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
The patients will only be included in the study if they meet all of the following criteria at Visit 1:
1. Written informed consent by the patient for study participation, prior to protocol specific procedures
2. Patients aged ≥18 years and equal or below 75 years
3. Out-patients able to perform their daily routine
4. Clinically confirmed localised idiopathic osteoarthritis of the hip, knee or fingers (as defined in the American College of Rheumatology, ACR guidelines)
5. Patients overall assessment of pain ≥40 mm (VAS)
6. Patients who require NSAID (nonsteroidal anti-inflammatory drug) therapy for at least 2 weeks
The patients will only remain in the study after screening if they meet the following criterion at Visit 2:
1. Patients overall assessment of pain ≥ 40 mm (VAS) |
|
| E.4 | Principal exclusion criteria |
Visit 1:
Disease specific criteria
1. Acute trauma
2. Prior total joint replacement of the area of interest or patients awaiting arthroplasty within the following 6 months
3. Belong to the ACR class IV
4. Generalized idiopathic osteoarthritis (e.g. Kellgren-Moore)
5. Secondary osteoarthritis, according to ACR post-traumatic
6. Congenital or developmental diseases (abbreviated)
7. Calcium deposition disease (abbreviated)
8. Other bone and joint disorders (abbreviated)
9. Complications of other diseases potentially associated with joint diseases(abbreviated)
10. Villous synovitis
11. Synovial chrondomatosis
12. Syphilitic haemopathy
Other diseases and conditions
13. History of asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis or nasal polyps, peptic ulcer in the past 2 years or gastrointestinal bleeding as well as cerebrovascular hemorhage in the past 5 years, porphyria, systemic lupus erythematodes or mixed connective tissue diseases, Crohns disease or ulcerous colitis
14. Severe uncontrolled cardiorespiratory insufficiency or hypertension
15. Disorder of haematopoiesis or blood coagulation defects
16. Impaired renal function: creatinine > 2x upper normal range limit
17. Impaired liver function: alanine amino transferase ALT > 2 x upper normal range limit and/or aspartate amino transferase AST > 2x upper normal range limit
18. History of malignancy or treatment of malignancy within 5 years prior to the study
Previous / Concomitant medication and therapy
19. In general, anti-inflammatory drugs (local, oral or intra-articular) are not allowed
during the study and results in the exclusion of the patient. The only exception is
the intake of low-dose (i.e. a maximum daily dose of 100 mg) ASS for treatment
of cardiac diseases.
20. Intake of long-acting NSAIDs during the last 7 days prior to baseline
21. Intake of short-acting NSAIDs (i.e. ≤ 12 h) during the previous 3 days (wash-out phase) prior to baseline
22. Intake of slow-release formulations of short-acting NSAIDs (i.e. ≤ 12 h) during the previous 4 days prior to baseline
23. Intake of analgesics during the last 12 hours prior to baseline
24. Drug therapy for osteoarthrosis other than NSAIDs, e.g. corticoids within the last 2 months
25. Intra-articular injections into the target joint of any type during the last 3 months and intra-articular injections into any other joint of any type during the last 4 weeks
26. Concomitant treatment with the following substance because of negative interactions: methotrexate, systemic corticoids, ciclosporine
27. Patients who are taking any of the following gastro-protective medications with the following criteria:
- Intake of proton pump inhibitors and H2 receptor antagonists within the last 3 months prior to as well as during the course of the study is excluded.
- Antacids are allowed if taken for calcium supplementation only but regular use must be stopped at screening (allowed no more than 2 times a week).
- Intake of misoprostol and sucralfate within the last month prior to the study is excluded.
28. Patients under the following concomittant treatment maybe included in the study
only under special precaution and supervison of the responsible investigator:
Digoxin, lithium, diuretics, antihypertensive agents, antidiabetics.
Patients taking anticoagulants are not allowed to participate in this trial.
29. Hypnotic drugs and/or muscle relaxants have to be stable during the two weeks before entry and during the study.
30. Physical therapy is allowed, but no more than 3 times per week. Ice or heat treatment is allowed if necessary up to 2 times daily. All other disease specific concomitant therapy during the study is not allowed.
Special restrictions for women
31. Pregnant or nursing women
32. Women of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration(abbreviated)
Others
33. Known or suspected hypersensitivity (including angioneurotic oedema or urticaria) to the study drugs or their excipients, analgesics (ASS), antipyretics or other NSAIDs
34. Alcohol abuse
35. Participation in another clinical study within the last month before start of this study or pervious participation in this study
36. Patient unable to comply with this protocol
Visit 2:
Previous / Concomitant medication
1. Intake of long-acting NSAIDs during the last 7 days prior to baseline
2. Intake of short-acting NSAIDs (i.e. ≤ 12 h) during the previous 3 days (wash-out phase) prior to baseline
3. Intake of slow-release formulations of short-acting NSAIDs (i.e.≤ 12 h) during the previous 4 days prior to baseline
4. Intake of analgesics during the last 12 hours prior to baseline
5. Antacids are allowed if taken for calcium supplementation only but regular use must be stopped at screening (allowed no more than 2 times a week). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Evaluation of the primary parameters (Diclo 150 HEXAL vs. Voltaren® Dispers):
Safety:
The primary safety variables of this study are the incidence of all drug related gastrointestinal adverse events and the incidence of all drug related adverse events.
Efficacy:
The primary efficacy variable of this study is the change of patients overall assessment of pain in the target joint (global pain) from baseline to week 2 (VAS) |
|
| 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 | 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 | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| 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
|
| The end of this clinical trial is defined by the last visit of the last patient. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
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