A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain (VERNE)

NCT01389284 Phase 3 COMPLETED Results posted

The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	300
Start date	2011-06
Completion	2011-09

Conditions

• Pain, Postoperative

Interventions

• Naproxen Sodium ER (BAYH6689)
• Naproxen Sodium IR (Aleve, BAYH6689)
• Naproxen Sodium ER Placebo
• Naproxen Sodium IR Placebo

Primary outcomes

• Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24) — From 0 to 24 hours post-dose
  SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.

Countries

United States