Table of Contents
- Trial overview
- Pain and surgery studies
- Studies in special patient groups
- Other conditions studied
- Phases, designs, and comparison groups
- Main endpoints and what they measure
- Study status and enrollment
Trial overview
These clinical trials study Ibuprofen in many different settings, not as a general medicine guide, but as part of research projects testing specific questions.[1] The studies include pain after surgery, acute pain in children and adults, migraine, rheumatoid arthritis, endometriosis, osteoarthritis, acute myocarditis, kidney stone care, and a newborn heart condition called patent ductus arteriosus.[2]
The trials use different research designs, including interventional studies, placebo-controlled studies, randomized studies, and one low-intervention study.[3] The populations are also varied, including children, adults, women with reproductive-age conditions, surgical patients, infants, and people with rare disease.[4]
Pain and surgery studies
Several trials focus on pain control after surgery or procedures.[5] One Phase 3 study after knee arthroscopy compared oral and intravenous analgesics and measured postoperative pain using the Numeric Rating Scale (NRS), which is a number-based pain scale.[6]
Another Phase 3 study in patients with acute severe postoperative pain tested an intravenous fixed-dose combination of Ibuprofen (arginate)-Tramadol hydrochloride against tramadol alone and placebo, using the SPID0-4h endpoint, which means the total change in pain over the first 4 hours.[7] A separate Phase 3 dental surgery study tested an oral combination of Ibuprofen (arginine)-tramadol HCl and measured pain relief over 12 hours with the Visual Analogue Scale (VAS), a pain line or scale used to show pain strength.[8]
In children, a Phase 3 trial studied postoperative pain after orthopedic trauma surgery and measured pain 3 months later with NRS, while another Phase 3 trial tested pain treatment after surgery in children and measured whether locoregional analgesia could help prevent persistent pain.[9] A Phase 3 trial in acute neck pain compared Ibuprofen medication with sham manipulation and placebo medication, using mean pain intensity on a 0-10 NRS as the primary outcome.[10]
A large low-intervention study after hip and knee arthroplasties looked at an 8-day postoperative course of Ibuprofen and measured a composite outcome, meaning several serious events were grouped into one main result.[11] Those events included death, heart attack, stroke, blood clots, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days.[11]
Studies in special patient groups
Some studies focus on groups with specific needs. A Phase 3 trial in extremely premature infants with patent ductus arteriosus (PDA) studied Ibuprofen alone versus Ibuprofen plus intravenous acetaminophen, with the main goal of reducing bronchopulmonary dysplasia or death before discharge.[12] PDA is a heart blood vessel that stays open when it should close after birth.[12]
A Phase 1 study in people with migraine without aura tested headache-inducing effects and included Ibuprofen as one of the oral study drugs.[13] Another Phase 1 study in women with migraine without aura also included oral Ibuprofen among the study interventions.[14] These studies measured the occurrence of migraine-like attacks, which means attacks with features similar to migraine during the observation period.[13]
A Phase 1/2 extension study in participants with isolated methylmalonic acidemia, also called MMA due to MUT deficiency, included oral Ibuprofen among several supportive medicines while mainly evaluating long-term safety of mRNA-3705.[15] The study population was people who had already taken part in earlier mRNA-3705 studies.[15]
Other conditions studied
Ibuprofen is also being studied in conditions outside routine pain care. A Phase 2 study in women with endometriosis included Ibuprofen among several treatment options and measured changes in the revised American Society of Reproductive Medicine score, called r-ASRM, as well as MRI changes in endometriotic nodules.[16] The r-ASRM score is a system used to grade disease severity during laparoscopy, which is a keyhole surgical look inside the body.[16]
A Phase 3 study in rheumatoid arthritis included oral Ibuprofen as a comparator or supportive treatment and measured how many patients reached ACR20 at Week 12, meaning at least 20% improvement in arthritis signs and symptoms.[17] Another Phase 2 study in chronic non-specific low back pain used Ibuprofen in comparison groups and measured change in mean pain intensity on an 11-point NRS from baseline to Week 7.[18]
A Phase 3 study in idiopathic osteoarthritis of the hip or knee tested a walking rehabilitation program helped by a one-off anti-inflammatory treatment and included Ibuprofen among the study medicines.[19] Its main success measure was whether the number of target movements increased by at least 30% without treatment stopping.[19]
A Phase 3 study in acute myocarditis tested Ibuprofen therapy for 3 weeks versus conventional treatment with paracetamol and measured change in late gadolinium enhancement on cardiac MRI at 6 months.[20] Late gadolinium enhancement is an MRI sign that can show damaged heart tissue.[20]
Phases, designs, and comparison groups
Most of the Ibuprofen studies listed here are Phase 3 trials, which usually means larger studies that compare one treatment with another treatment or with placebo.[3] There are also Phase 2 studies, a Phase 1/2 extension study, and Phase 1 studies that focus on early testing or special response questions.[3]
Many trials are randomized, which means participants are assigned by chance to a study group, and some are double-blind, meaning neither the participants nor the researchers know who gets which treatment during the study.[21] Several studies compare Ibuprofen with placebo, active treatment, or another pain medicine, which helps researchers see whether the study treatment works better than the comparison option.[7][8][17]
Some studies use Ibuprofen as the main treatment being tested, while others include it as part of a combination or as a comparison arm.[12][16][20]
Main endpoints and what they measure
The trials measure different kinds of endpoints, depending on the condition being studied.[1] In pain studies, the main endpoints are often pain scores over time, such as NRS, VAS, or SPID measures, which track how pain changes after treatment starts.[6][7][8]
In disease-focused studies, the endpoints may be response rates, imaging changes, or clinical scores.[16][17][20] Examples include ACR20 in rheumatoid arthritis, stone clearance after kidney stone treatment, r-ASRM and MRI changes in endometriosis, and late gadolinium enhancement in myocarditis.[11][16][17][20]
Safety endpoints are also important. One major study after orthopedic surgery measured a broad safety composite that included serious events such as death, blood clots, bleeding, kidney failure, and readmission within 90 days.[11] Another pediatric study measured treatment-emergent adverse events with Combogesic IV, a product containing paracetamol and Ibuprofen.[22]
Study status and enrollment
The trial list includes studies that are authorised, completed, and withdrawn.[1] Enrollment ranges from small early studies with 14 to 41 participants to larger studies with hundreds or thousands of participants, including one orthopedic surgery safety study with 2,904 participants.[1][11]
This spread in size shows that Ibuprofen is being studied in both focused research settings and large comparative trials.[1]
