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Phase III, double-blind, randomised, placebo- and active treatment-controlled clinical trial to evaluate the analgesic efficacy and safety of a combination of ibuprofen (arginate)-tramadol hydrochloride 400-37.5 mg, administered intravenously to patients with acute severe postoperative pain.
EU CTIS ID: 2023-505687-11-00
What this study is testing
To assess whether the fixed-dose combination of ibuprofen (arginate)-tramadol hydrochloride 400-37.5 mg IV/4 hours, administered post-operatively to patients with severe pain, achieves non-inferior pain control at 4 h as compared to the administration of 100 mg of tramadol alone and better pain control than 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 grant written informed consent (IC) and who are able to comply with the scheduled study procedures. Informed consents obtained verbally during the telephone consultation, documented in the medical record and signed by patients at the next visit to the study site will be accepted.
- Patients aged ≥ 18 years at the screening visit.
- Patients with body mass index ≥ 18.5 and < 40 kg/m2 at the screening visit.
- Patients scheduled for open or laparoscopic surgery for myomectomy, total or partial hysterectomy due to benign conditions, oophorectomy, salpingo-oophorectomy, cholecystectomy, haemorrhoidectomy or tonsillectomy.
- Patients with an American Society of Anesthesiologists (ASA) anaesthesia risk score of I or II.
- After surgery and prior to randomisation: Patients with a Numeric Rating Scale (NRS) for pain score of ≥ 6 after surgery.
You likely can't join if
- Patients with a history of allergy or hypersensitivity to the study medication, rescue medication or any of the excipients.
- Serious unresolved infection on the day of surgery.
- Any other disease, relevant laboratory test alteration or condition which in the investigator’s opinion could interfere with the results of the study or constitute a risk for the subject if he/she participates in the study.
- Patients currently enrolled in or who have participated in a clinical trial with medicinal products or devices in the 30 days prior to the screening visit.
- Women who are pregnant or breastfeeding.
- History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
See the full eligibility criteria
- Patients who grant written informed consent (IC) and who are able to comply with the scheduled study procedures. Informed consents obtained verbally during the telephone consultation, documented in the medical record and signed by patients at the next visit to the study site will be accepted.
- Patients aged ≥ 18 years at the screening visit.
- Patients with body mass index ≥ 18.5 and < 40 kg/m2 at the screening visit.
- Patients scheduled for open or laparoscopic surgery for myomectomy, total or partial hysterectomy due to benign conditions, oophorectomy, salpingo-oophorectomy, cholecystectomy, haemorrhoidectomy or tonsillectomy.
- Patients with an American Society of Anesthesiologists (ASA) anaesthesia risk score of I or II.
- After surgery and prior to randomisation: Patients with a Numeric Rating Scale (NRS) for pain score of ≥ 6 after surgery.
- Patients with a history of allergy or hypersensitivity to the study medication, rescue medication or any of the excipients.
- Serious unresolved infection on the day of surgery.
- Any other disease, relevant laboratory test alteration or condition which in the investigator’s opinion could interfere with the results of the study or constitute a risk for the subject if he/she participates in the study.
- Patients currently enrolled in or who have participated in a clinical trial with medicinal products or devices in the 30 days prior to the screening visit.
- Women who are pregnant or breastfeeding.
- History of bronchospasm, asthma, rhinitis, angioedema or urticaria associated with the use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
- Active or recurrent peptic ulcer and/or gastrointestinal bleeding, or a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
- Bleeding diathesis or coagulation disorders.
- Patients with moderate or severe renal, liver or heart failure (New York Heart Association [NYHA] class III-IV).
- Patients with uncontrolled epilepsy.
- History of dependence on drugs of abuse: alcohol, opiates, hypnotics, amphetamines, cocaine, hallucinogens, cannabis or synthetic drugs of abuse.
- Patients under treatment with any medicinal product that should not be administered due to the risk of adverse interactions with the study drug or interference with the study assessments (indicated in section 9.1.10. of the protocol “Prohibited Medication”).
- A surgical procedure during the study other than that initially planned or lasting more than 4 hours, and which in the investigator’s opinion could have an impact on the degree or type of post-operative pain and the analgesic response, thereby interfering with the interpretation of the study results.
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, 18-64 years, 65+ 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.