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placebo with hydrocodone/APAP PRN
Hydrocodone is an opioid agonist that binds to mu opioid receptors in the central nervous system to reduce pain perception, while acetaminophen (APAP) inhibits prostaglandin synthesis to provide additional analgesic and antipyretic effects.
Hydrocodone is an opioid agonist that binds to mu opioid receptors in the central nervous system to reduce pain perception, while acetaminophen (APAP) inhibits prostaglandin synthesis to provide additional analgesic and antipyretic effects. Used for Moderate pain (acute or chronic pain conditions).
At a glance
| Generic name | placebo with hydrocodone/APAP PRN |
|---|---|
| Also known as | placebo with Lortab PRN |
| Sponsor | VA Office of Research and Development |
| Drug class | Opioid analgesic combination |
| Target | Mu opioid receptor (hydrocodone); COX enzymes (acetaminophen) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Hydrocodone acts as a mu opioid receptor agonist, modulating pain signals in the brain and spinal cord. Acetaminophen works through inhibition of cyclooxygenase (COX) enzymes, reducing prostaglandin production. The combination provides synergistic analgesia for moderate pain. This formulation is being studied with placebo control in a VA research context.
Approved indications
- Moderate pain (acute or chronic pain conditions)
Common side effects
- Constipation
- Nausea
- Dizziness
- Drowsiness
- Respiratory depression
- Hepatotoxicity (acetaminophen)
Key clinical trials
- Post-Op Pain Control for Prophylactic Intramedullary Nailing. (PHASE3)
- Effect of Ibuprofen on Postoperative Opiate Medication Use and Shoulder Functional Outcomes (NA)
- Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy (PHASE3)
- Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair (PHASE4)
- Steroids in Total Knee Arthroplasty (PHASE4)
- Acupuncture for Pain in the Emergency Department (EARLY_PHASE1)
- Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT) (PHASE4)
- Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients (EARLY_PHASE1)
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 |
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