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Randomised, double-blind, placebo-controlled, active-treatment clinical trial to assess the analgesic efficacy and safety of an oral combination of ibuprofen (arginine) -tramadol HCl administered to patients with moderate to severe pain after undergoing dental surgery.
EU CTIS ID: 2024-517807-35-00
What this study is testing
To assess whether the combination of ibuprofen (arginine) and tramadol HCl 400/37.5 mg, administered orally every 6 hours to patients presenting moderate to severe pain after dental extraction (third molars), achieves better pain relief, expressed as a difference in the SPID(0-12) hours variable, than its active components administered as monotherapy and compared to placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures
- Patients ≥ 18 years at screening visit.
- With a body mass index ≥ 18.5 and < 35 kg / m2 at the screening visit (BMI = weight/height2 = kg/m2).
- Scheduled for surgical extraction under local anaesthetic, of at least 2 third molars, at least one of them lower, and at least one of them impacted requiring bone removal.* Inclusion criterion 4 will be verified at the screening visit.
- That they agree not to take analgesics apart from those defined by the protocol as rescue medication and the study medication, 24 hours before the start of surgery until 48 hours after the end of the study medication.
- Patients who achieve pain on the VAS ≥ 55 mm within the first 3 hours after the end of surgery.**Inclusion criterion 6 will be verified at visit 1 prior to randomisation.
You likely can't join if
- Patients with a history of allergy or hypersensitivity to study medication, rescue medication, acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID) or opioid, or any of their excipients.
- History of drug dependency: alcohol, opiates, hypnotics, amphetamines, cocaine, hallucinogens, cannabis or synthetic drugs.
- Patients who have consumed analgesics, muscle relaxants or anti-inflammatories (including prescription and over-the-counter drugs) 24 hours prior to the start of surgery, or 5 days prior in the case of consumption of COX-2 inhibitors, up to 48 hours after the end of the study medication.
- Patients in treatment with any other medicinal product that should not be administered due to the risk of adverse interactions with the study medication or interference with the assessments: listed in protocol section 10.2.2 Prohibited medication.
- Patients who have suffered complications during surgery, a duration of surgery of more than 1 hour or who have required re-anaesthesia (after reaching the appropriate level of anaesthesia).
- Unresolved infection on the day of surgery if the surgery is severe or requires treatment with systemic antibiotic therapy.
See the full eligibility criteria
Who can join
- Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures
- Patients ≥ 18 years at screening visit.
- With a body mass index ≥ 18.5 and < 35 kg / m2 at the screening visit (BMI = weight/height2 = kg/m2).
- Scheduled for surgical extraction under local anaesthetic, of at least 2 third molars, at least one of them lower, and at least one of them impacted requiring bone removal.* Inclusion criterion 4 will be verified at the screening visit.
- That they agree not to take analgesics apart from those defined by the protocol as rescue medication and the study medication, 24 hours before the start of surgery until 48 hours after the end of the study medication.
- Patients who achieve pain on the VAS ≥ 55 mm within the first 3 hours after the end of surgery.**Inclusion criterion 6 will be verified at visit 1 prior to randomisation.
What rules you out
- Patients with a history of allergy or hypersensitivity to study medication, rescue medication, acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID) or opioid, or any of their excipients.
- History of drug dependency: alcohol, opiates, hypnotics, amphetamines, cocaine, hallucinogens, cannabis or synthetic drugs.
- Patients who have consumed analgesics, muscle relaxants or anti-inflammatories (including prescription and over-the-counter drugs) 24 hours prior to the start of surgery, or 5 days prior in the case of consumption of COX-2 inhibitors, up to 48 hours after the end of the study medication.
- Patients in treatment with any other medicinal product that should not be administered due to the risk of adverse interactions with the study medication or interference with the assessments: listed in protocol section 10.2.2 Prohibited medication.
- Patients who have suffered complications during surgery, a duration of surgery of more than 1 hour or who have required re-anaesthesia (after reaching the appropriate level of anaesthesia).
- Unresolved infection on the day of surgery if the surgery is severe or requires treatment with systemic antibiotic therapy.
- Any other disease, relevant laboratory abnormality or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study (e.g., patients with acute pain of different origin or location at the time of surgery).
- Patients who have received an experimental drug or used an experimental medical device within 30 days prior to the screening visit.
- Pregnant or breastfeeding women.
- History of asthma, bronchospasm, urticaria or angioneurotic oedema.
- Active peptic ulcer, gastrointestinal disorders due to NSAIDs, active gastrointestinal bleeding or history of gastrointestinal bleeding.
- Haemorrhagic diathesis or other coagulation disorders.
- Current renal or hepatic insufficiency; or a recent history of moderate or severe impairment of renal, hepatic or cardiac function.
- Epilepsy.
- Crohn's disease or ulcerative colitis.
- Patients who for other reasons should not receive treatment with NSAIDs or tramadol.
- Patients who, apart from the anaesthetic procedure, cannot abstain from alcohol, psychotropic drugs or sedatives (e.g. benzodiazepines) 72 hours before the start of surgery until 48 hours after the end of the study treatment.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.