Opioid-sparing Effects of SoluMatrix Indomethacin in a Phase 3 Study in Patients With Acute Postoperative Pain
| Autor: | Melanie Lauterio, Lynn R. Webster, Jennifer Nezzer, Clarence L. Young, Joseph A. Markenson, Christopher Gharibo, Charles Argoff, Daniel Solorio |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Randomization Adolescent Nausea Indomethacin Phases of clinical research Capsules Placebo Loading dose Bunion law.invention 03 medical and health sciences Young Adult 0302 clinical medicine Randomized controlled trial law medicine Humans Adverse effect Aged Pain Measurement Pain Postoperative business.industry Anti-Inflammatory Agents Non-Steroidal 030208 emergency & critical care medicine Middle Aged Analgesics Opioid Anesthesiology and Pain Medicine Treatment Outcome Anesthesia Celecoxib Female Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | The Clinical journal of pain. 34(2) |
| ISSN: | 1536-5409 |
| Popis: | OBJECTIVES To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy. METHODS This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg 3 times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg 3 times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo. Patients were permitted to receive opioid-containing rescue medication throughout the study. The proportion of patients who used rescue medication and the amount of rescue medication used on the first (0 to 24 h) and second (>24 to 48 h) days following initial dose of study medication, as well as time to first rescue medication use, were assessed. RESULTS Significantly fewer patients who received SoluMatrix indomethacin 40 or 20 mg 3 times daily used opioid-containing rescue medication on day 1 compared with those receiving placebo (P≤0.034), and fewer patients in all active treatment groups used rescue medication during the second day compared with those in the placebo group (P |
| Databáze: | OpenAIRE |
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