A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain

NCT01118273 Phase 4 COMPLETED Results posted

The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination

Details

Lead sponsor	Bayer
Phase	Phase 4
Status	COMPLETED
Enrolment	162
Start date	2008-01
Completion	2008-02

Conditions

• Sleep

Interventions

• Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
• Naproxen Sodium 440 mg (BAYH6689)
• Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
• Naproxen Sodium 220 mg (BAYH6689)
• DPH 50mg
• Ibuprofen 400 mg / Diphenhydramine citrate 76 mg

Primary outcomes

• Total Sleep Time Measured by Actigraphy — Up to 10 hours
  Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as "awake" from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.

Countries

United States