Abstract:
BACKGROUND:Naproxen is an NSAID with documented efficacy in pain management; however, it is associated with serious dose-related adverse events. A lower-dose naproxen drug product with comparable efficacy to commercially available naproxen could address these concerns. We studied the efficacy and safety of naproxen submicron particle capsules in patients with acute post-surgical dental pain. METHODS:A phase 2, multicenter, randomized, single-dose study (NCT01229228) enrolled 254 patients (18-34 years old) undergoing third molar extraction. Patients who experienced moderate-to-severe pain ≤6 h following surgery received naproxen submicron particle capsules 200 or 400 mg, naproxen tablets 250 or 500 mg, or placebo. The primary efficacy parameter was patient-reported total pain relief over 0-12 h following administration of study medication. Secondary efficacy parameters included patient-reported total pain relief over 0-4 and 0-8 h; pain intensity assessments from 0 to 4, 0 to 8, and 0 to 12 h; and time to onset of analgesia. Safety and tolerability were also assessed. RESULTS:Naproxen submicron particle capsules 200 mg (25.9 ± 2.0; 95% CI 21.9-29.8), naproxen tablets 250 mg (24.4 ± 2.0; 95% CI 20.4-28.3), naproxen submicron particle capsules 400 mg (31.9 ± 2.0; 95% CI 28.1-35.8), and naproxen tablets 500 mg (28.5 ± 2.0; 95% CI 24.7-32.4) groups experienced greater pain relief over 12 h compared with placebo (P < 0.001). Similar trends were observed for secondary outcomes of total pain relief over 0-4, 0-8 h, and time to onset of analgesia. Adverse events were generally similar across all treatment groups. CONCLUSION:Lower-dose naproxen submicron particle capsules provided effective analgesia in acute post-surgical dental pain and warrant further evaluation as a potentially promising treatment for acute pain conditions.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Young CL,Strand V,Altman R,Daniels Sdoi
10.1007/s12325-013-0057-9subject
Has Abstractpub_date
2013-10-01 00:00:00pages
885-96issue
10eissn
0741-238Xissn
1865-8652journal_volume
30pub_type
杂志文章,多中心研究,随机对照试验abstract:INTRODUCTION:This study aimed to demonstrate the clinical utility of non-invasive multigene Cxbladder urine tests in reducing the overall number of diagnostic tests and invasive procedures used in the clinical evaluation of patients presenting with microhematuria, a key symptom of urothelial carcinoma (UC). There is a ...
journal_title:Advances in therapy
pub_type: 杂志文章
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abstract::Endocrine therapy (ET) is integral to the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Aromatase inhibitors (AIs; e.g., anastrozole, letrozole, exemestane), selective estrogen receptor modulators (e.g., tamoxifen), and the selec...
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journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
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journal_title:Advances in therapy
pub_type: 已发布勘误
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pub_type: 临床试验,杂志文章,多中心研究
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pub_type: 杂志文章,meta分析
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