Randomized, double blind, placebo-controlled, active treatment clinical trial to assess the analgesic efficacy and the safety of an oral ibuprofen (arginine)-tramadol HCI combination administered to patients with moderate to severe pain after undergoing a dental surgery

Farmalíder S.A.0 sites346 target enrollmentAugust 26, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 26, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Farmalíder S.A.

•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 \< 35 kg/m2 in the screening visit (BMI\=weight/height2\= kg/m2\).
•4\. Scheduled for a surgical extraction under local anesthesia of at least 2 third molars, at least one of them lower and at least one of them impacted requiring bone removal.
•5\. Patients who accept not taking painkillers apart from the ones defined by the protocol as rescue medication and the study medication, from 24 hours before the beginning of the surgery until 48 hours after finishing the study medication.
•6\. Patients who reach a pain in the VAS \= 55 mm within the first 3 hours after having finished the surgery.
•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 346

•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.