Dexibuprofen 400 mg Sachet Versus Ibuprofen 400 mg Sachet in Patients With Osteoarthritis of the Hip or Knee

Study Overview
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Brief Summary
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Medical condition under investigation: Osteoarthritis of the hip or knee Number of patients planned: 480 adult patients Main objective: To evaluate and compare the tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee Secondary objectives: To compare the overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee

Official Title
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Prospective, Clinical Trial to Investigate Safety, Tolerability and Efficacy of Dexibuprofen Gebro 400 mg Powder for Oral Suspension (Test) Compared to Ibuprofen 400 mg Powder for Oral Suspension (Reference) in Patients Suffering From Osteoarthritis of the Hip or Knee

Conditions
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Osteoarthritis of the Hip or Knee

Intervention / Treatment
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* Drug: Dexibuprofen
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female patients aged between 18 and 75 years everyday joint pain for the past three months global pain intensity in the involved joint (hip or knee) of moderate to severe within the last 48 h Exclusion Criteria: acute inflammation or ischaemic necrosis paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology hip/knee arthropathy due to diabetes mellitus Charcot's joint villous synovitis chondromatosis of the synovium patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexibuprofen<br>Dexibuprofen 400 mg powder for oral suspension | Drug: Dexibuprofen<br>* 400mg powder for oral suspension, daily dose 800mg<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen 400 mg powder for oral suspension | Drug: Ibuprofen<br>* 400mg, powder for oral suspension, daily dose 1600mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability profile of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall efficacy of Dexibuprofen Gebro 400 mg powder for oral suspension compared to Ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee |  | 14 days |