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

Phase 1

• Conditions: Moderate-severe somatic pain; MedDRA version: 20.0Level: HLTClassification code 10044049Term: Dental pain and sensation disordersSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2020-005530-15-ES
• Lead Sponsor: Farmalíder S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-26
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 346

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 < 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified