Symptomatic treatment for pain and inflammation associated with irritations of degenerative joint diseases, e.g. ostheoarthitis of the hip, knee or fingers MedDRA version: 7.1 Level: LLT Classification code 10031161
Conditions
Interventions
Trade Name: Diclac ® 150 ID
Product Name: Diclac ® 150 ID
Product Code: Diclo 150 HEXAL
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Diclofenac-sodium
Concentration unit: mg milli
Sponsors
HEXAL AG
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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: 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. Physic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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) ;Secondary Objective: 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;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 | — |
Countries
Germany, Latvia, Lithuania
Outcome results
None listed