Who is sponsoring NCT00720057?

NCT00720057 is sponsored by Bayer.

What drugs are being tested in NCT00720057?

Interventions: Naproxen Sodium ER (BAYH6689), Placebo.

What is the status of NCT00720057?

NCT00720057 is currently COMPLETED.

Last reviewed 2015-08-12 · How we verify

A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain

NCT00720057 Phase 3 COMPLETED Results posted

To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	312
Start date	2008-06
Completion	2008-08

Conditions

Toothache

Interventions

Naproxen Sodium ER (BAYH6689)
Placebo

Primary outcomes

Summed Pain Intensity Difference (SPID) — 0 to 24 hours post dose
Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively.

Countries

United States