Moderate-severe somatic pain MedDRA version: 20.0 Level: HLT Classification code 10044049 Term: Dental pain and sensation disorders System Organ Class: 100000004856
Conditions
Interventions
Product Name: Ibuprofeno (arginina)/Tramadol HCl
Pharmaceutical Form: Granules for oral solution
INN or Proposed INN: Ibuprofen
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concentration
Sponsors
Farmalíder S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who grant their informed consent in writing and who are capable and willing to comply with all scheduled study visits and procedures. 2. Patients = 18 years old in the screening visit. 3. With body mass index = 18.5 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with history of allergy or hypersensitivity to the study medication, rescue medication, acetylsalicylic acid or to any other non-steroidal anti-inflammatory (NSAID) or opiate, or to any other of its excipients. 2. History of asthma, bronchospasm, hives or angioneurotic edema. 3. Active peptic ulcer, gastrointestinal disorders due to NSAID, active gastrointestinal hemorrhage or history of gastrointestinal hemorrhage. 4. Hemorrhagic diathesis or other clotting disorders. 5. Current kidney or liver failure; or recent history of moderate or serious kidney, liver or heart failure. 6. Epilepsy. 7. Crohn disease or ulcerous colitis. 8. Patients that for other causes should not receive treatment with NSAIDS or tramadol. 9. Patients who, apart from the anesthetic procedure, cannot refrain from consuming alcohol, psychotropic drugs, or sedatives (e.g., benzodiazepines) from 72 hours before the beginning of the surgery until after 48 hours after ending the study treatment. 10. History of drug abuse dependency: alcohol, opiates, hypnotics, amphetamines, cocaine, hallucinogens, cannabis, or synthetic drugs. 11. Patients who have consumed painkillers, muscle relaxants or anti-inflammatory medicines (including the prescription and over-the-counter ones) for 24 hours prior to the initiation of the surgery, or on the 5 previous days in case of consumption of COX-2 inhibitors, until 48 hours after ending the study medicinal product. 12. Patients on treatment with any other medication that should not be administered due to the risk of adverse interactions with the study medication or of interference with the assessments: stated in protocol section 10.2.2 Concomitant Medication. 13. Patients who have suffered complications during surgery, a duration of over 1 hour or that have required re anesthesia (after reaching an adequate level of anesthesia). 14. Unresolved infection on the day of surgery if it is serious or requires treatment with systemic antibiotherapy. 15. Any other disease, relevant analytical alteration, or condition that, at the discretion of the investigator, may constitute a risk to the participant or interfere with the study results (e.g., patients with acute pain of different origin or location in the moment of surgery). 16. Patients who have received an experimental drug or used an experimental medical device in a period of 30 days before the screening visit. 17. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Sum of the Pain Intensity Differences from the administration initiation until after 12 hours (SPID0-12h), measure through the Visual Analogical Scale (VAS).;Timepoint(s) of evaluation of this end point: 0.75 h, 1.5 h, 3 h, 4.5 h, 6 h, 7.5 h, 9 h, 10.5 h and 12 h from the start of the 1st administration of the medication;Main Objective: To assess if the ibuprofen (arginine) and tramadol hydrochloride 400/37.5 mg, orally administered every 6 hours to patients who present moderate to severe pain after dental extraction surgery (third molars), achieve better pain control, expressed as difference of the variable SPID (0-12) hours, that its active components administered in monotherapy and compared to placebo.;Secondary Objective: • To describe and compare the following analgesic efficacy parameters obtained in each study treatment group: - Pain Visual Analogue Scale (VAS) punctuation and differences of pain intensity with regard to baseline pain (PIDt) - Area Under the Curve of the differences in pain intensity from the beginning of the administration until 12 horas2 after - Sum the differences in pain intensity regarding baseline pain 6 hours (SPID0-6h) from the beginning of the medication administration - Time until the first pain relief - Percentage of patients responding to each treatment - Demand of each standardized rescue medication level - Time to rescue medication administration • To assess the safety and tolerability of each treatment under study | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: ? Efficacy Assessment - From time 0 to 48 hours - From time 0 to 12 hours - From time 0 to 6 hours - From time 0 to 12 hours - From time 0 to first pain relief - From time 0 to the end of the study - From time 0 to 12 hours and 48 hours - From time 0 to first rescue administration ? Safety Assessment - From time 0 to the end of the study - Visit 0, visit2 - From time 0 to the end of the study;Secondary end point(s): ? Efficacy Assessment - Pain intensity (PI) and pain intensity difference (PID) in the times of scheduled assessment until 48 hours from the start of the medication administration to studies. - Area Under the Curve of the differences of pain intensity during the first 12 hours of the medication administration to study. - Sum of the differences of pain intensity with regard to the baseline one, after 6 hours (SPID0-6h) from the start of the medication administration to study. - Rate of responding patients defined as the percentage of patients with a SPID(0-12h) = ds. - Time until the first pain relief (pain intensity decrease 33%). - Proportion of patients using rescue medication. - Total use of the different standardized levels of rescue medication from the start of the treatment until 12 and until 48 hours (measured in number of rescues required from each level). - Time until the first rescue administration from the start of the medication administration to study. ? Safety Assessment - Vital signs (body temperature, heart rate and blood pressure) and general physical exploration. - Analytical alterations. - Adverse events. | — |
Countries
Spain
Contacts
Public ContactSTART UP UNIT
SERMES PLANIFICACION S.L
Outcome results
None listed