Moderate to severe pain following dental surgery.
Conditions
Interventions
Product Name: Ibuprofen (arginine)/Tramadol HCl 400/37,5 mg
Product Code: test
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ibuprofeno
Current Sponsor code: test
Other descriptive name: IBU
Sponsors
Laboratorios Farmalider S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Able to understand and sign consent informed before participating in the study and willing to comply with all visits and procedures scheduled and collect the information required by the protocol. 2. Men and women of both sexes at least 18 years of age. 3. For women: postmenopausal women or unable by surgery, not pregnant women of child-bearing age who use acceptable methods of birth control and normal menstrual period 3 months before the clinical study. 4. Body weight of more than 50 Kg and less than 110 Kg. 5. Programed people to ambulatory surgical dental removal, under local anesthesia, at least 2 impacted third molars which require bone removal. If only 2 third molars are removed these should be ipsilaterals and at least one of them should require bone removal. 6. People with moderate to severe pain, reaching at least 45 mm in EVA scale for the first 4 hours after surgery. 7. Surgery without complications, surgery time no more than 1 hour and without re-anesthesia. 8. Must accept don´t take analgesics, except rescue medication until treatment described in the Protocol, up to 24 hours after first administration of study medication. 9. With ordinary or without relevant abnormalities medical records and physical exploration, to the discretion of the investigator. 10. People who have not used up analgesics (including those for prescription and non-prescription sale) until 48 hours before the surgery, or 5 days early in the event of consumption of COX-2 inhibitors. 11. For women of childbearing, they should have a negative pregnancy test prior to randomization. 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 384 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. History of allergy or hypersensitivity to the study medication, to the rescue medication or to the any other NSAID, to the opiates or to the acetylsalicylic acid. 2. History of asthma, bronchospasm, acute rhinitis, nasal polyps, hives or angioneurotic edema. 3. History of peptic ulcers, gastrointestinal disorders caused by NSAID, gastrointestinal bleeding or others active bleedings. 4. Renal, hepatic and cardiac dysfunction moderate to severe. 5. Coagulation disorders. 6. Uncontrolled seizure disorders. 7. Crohn's disease or ulcerative colitis. 8. History of drug addiction and alcohol abuse. According to the study, alcohol abuse is defined in the following manner: average weekly consumption >21 units (men) and >14 units (women), or average daily consumption >3 units (men) and >2 units (women) [1 unit = 125 ml of wine, 200ml of beer, 25ml of liquor] 9. According to the investigator, patients who are not suitable candidates to take the study medication and the rescue medication based on their medical history, concomitant medication systemic concurrent diseases described in the corresponding technical sheets (warnings, precautions, contraindications and adverse events) of ibuprofen, tramadol, paracetamol and metamizole ( paracetamol and metamizole are rescue medication). 10. Inability to abstain from alcohol, psychotropic drugs and sedative medications or others drugs banned (*) until 48 hours or 5 half-lives (the longest possible) before the start of surgery and until 24 hours after of administration of study medication. (*)different analgesics from study medication, anticoagulants, thrombolytic and antiplatelet agents, corticosteroids, MAO inhibitors, antiepileptic drugs, antipsychotics, SSRIs and tricyclic antidepressants, lithium, methotrexate, sulfonamides. 11. Patients using and don´t be able to interrupt other drugs, prescribed or not, that could interfere with the study medication and study procedures, or could endanger the patient´ safety according to related documentation with the medications included in the study and the rescue medication, until 48 hours or 5 half-lives (the longest possible) before the start of surgery and until 24 hours after of administration of study medication. 12. Patients who have taken an experimental medication or patients who have used an experimental medical device within 30 days before to selection. 13. Pregnant or nursing women. 14. History of any liver disease or disorder which, according to investigator, might constitute a risk to the patient or to alter the results of the study (e.g. patients with severe pain of different origins or location at the surgery moment.) 15. Patients who cannot meet the requirements of the study or must not take part according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective consists on evaluating the analgesic efficacy of oral ibuprofen arginine and tramadol hydrochloride fixed combination versus each component single and placebo, in patients with moderate to severe pain after dental surgery.;Secondary Objective: Secondary objectives: To assess the safety and tolerability of ibuprofen arginine and tramadol hydrochloride fixed combination and compared to each components single.;Primary end point(s): ? Main parameter for judging the efficacy and main efficacy analysis: The main variable of the study will be the pain intensity 6 hours after the start of treatment, measured as of EVA points (0-100) at that moment ;Timepoint(s) of evaluation of this end point: 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sum of Pain Intensity Differences (SPID), pain intensity difference (PID), pain relief (PAR), total pain relief (TOTPAR), the percentage of patients that respond to treatment, the percentage of patient that needed rescue medication, time to first intake of rescue medication, time to achieve pain relief and global assessment of study medication.;Timepoint(s) of evaluation of this end point: 9 months | — |
Countries
Spain
Contacts
Public ContactAntonio Bazán Carbonell
Fundación Teófilo Hernando
Outcome results
None listed