Osteoarthritis of the hip or knee
Conditions
Interventions
Trade Name: Spidifen
Product Name: Ibuprofen powder for oral suspension
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: Ibuprofen
CAS Number: 57469-77-9
Current Sponsor code: Ibup
Sponsors
Gebro Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: male or female patients; age between 18 and 85 years; informed consent of the patient; 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 [on the Likertscale: mild, moderate, severe, extreme]: mild: no impairment of the quality of life, no disorder of night pain, pain at different functions less than 1 hourmoderate: recognizable impairment of the quality of life, pain at single functional sequences, pain dimension is limited to any time of the daysevere: pain impairment of the quality of life at numerous activities of daily lifeextreme: marked impairment of the quality of life over 24h attached with clear pain description; previous treatment with NSAIDs with half-life of > 12 hours after a wash-out period of 5 times of half-life 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: Acute inflammation; ischaemic necrosis; paget’s disease of the hip/knee joint; chondrocalcinosis of the hip/knee joint; ochronosis of the hip/knee joint; haematochromatosis of the hip/knee joint; hip/knee arthropathy in haemophiliacs; unilateral or bilateral inflammatory hip/knee arhtropathy as single manifestation (CP, Bechterew’s disease, psoriasis etc.) with and without involvement of other joints; infectious; slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology; hip/knee arthropathy due to diabetes mellitus; Charcot’s joint; villous sinovitis; chondromatosis of the synovium; contraindication of the trial substance (see SmPC); patients tending to allergies or hypersensitivity to non-steroidal anti-inflammatory agents (triggering asthma attacks or history of urticaria or acute rhinitis); 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; patients with chronic respiratory tract infections, asthma; patients with impaired haematopoesis, porphyria, haemorrhagic diathesis; several renal or hepatic disease; uncontrolled hypertension (constant random diastolic blood pressure in spite of regular medication of at least two measurements > 180 and/or 110); severe heart failure (NYHA III-IV); decompensated diabetes mellitus (at requirement: bland-blood sugar over 400 mg/dl); patients with autoimmune disease (e.g. lupus erythematodes); positive urine pregnancy test at the onset of trial (if required); pregnant woman; breast-feeding woman; adolescents and children; participation in another clinical trial less than 30 days ago; simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Objective: 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;Primary end point(s): Safety and Tolerability based on gastrointestinal drug related Adverse Events;Timepoint(s) of evaluation of this end point: Day 1-15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Sum of pain intensity differences (SPID), time-weighted (0 to t): For pain at night, pain after rising from resting position, pain at rest and pain on motion, using the visual analogous scale (VAS: horizontal 100mm) determined by calculating the pain intensity difference (PID) at each time point (t) from baseline. SPID is calculated as the sum of the PIDs weighted over the time between observations as follows: PID timet = pain intensity timet – pain intensity baseline SPID = ? PID timet x [time (hours) elapsed since previous observation] - Total pain relief (TOTPAR), time weighted (0 to t): Is calculated as the weighted sum of pain relief scores on the 5-point verbal rating scale (VRS). For time to event data these measures are calculated as follows: TOTPAR0-t: correspondingly calculated from the pain relief scores. TOTPAR = ?Rt x [time (hours) elapsed since previous observation] Rt ……pain relief score at time t - Peak PID, time to Peak PID, time to reduce baseline pain by at least 50% using the VAS: The maximum PID from baseline (VAS) and total number of hours over which baseline pain was reduced by at least 50% using the VAS Secondary criteria: Also a global subjective judgement of tolerability and efficacy of therapy by investigator and patient on the basis of a five-point verbal rating score (VRS; 1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor) on the trial exit day will be performed. ;Timepoint(s) of evaluation of this end point: Day 1, Day 3 and Day 15 | — |
Countries
Austria
Contacts
Public ContactDr. Norbert Eller
Gebro Pharma GmbH
Outcome results
None listed