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Placebo to Acetaminophen/Paracetamol
Acetaminophen reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system.
Acetaminophen reduces pain and fever by inhibiting prostaglandin synthesis in the central nervous system. Used for Mild to moderate pain, Fever reduction.
At a glance
| Generic name | Placebo to Acetaminophen/Paracetamol |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Non-opioid analgesic and antipyretic |
| Target | Cyclooxygenase (COX) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
Acetaminophen (paracetamol) is a non-opioid analgesic and antipyretic that works primarily through inhibition of cyclooxygenase (COX) enzymes in the brain and spinal cord, reducing prostaglandin production. This leads to decreased pain signal transmission and lowering of the hypothalamic temperature set point. Unlike NSAIDs, it has minimal peripheral anti-inflammatory effects.
Approved indications
- Mild to moderate pain
- Fever reduction
Common side effects
- Hepatotoxicity (at high doses)
- Nausea
- Rash
- Allergic reactions
Key clinical trials
- Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters (PHASE2)
- Jaw Muscle Pain Post Wisdom Molar Surgery (PHASE2)
- Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy (NA)
- Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen (PHASE2, PHASE3)
- Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis (NA)
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants (PHASE2)
- High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer (PHASE3)
- Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo to Acetaminophen/Paracetamol CI brief — competitive landscape report
- Placebo to Acetaminophen/Paracetamol updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI