Study of Long-Acting Acetaminophen in Postoperative Dental Pain

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: Acetaminophen ER; Drug: Placebo

• Registration Number: NCT01960114
• Lead Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Disposition First Submitted: 2015-03-23
• Disposition First Submitted QC: 2015-03-23
• Disposition First Posted: 2015-04-13
• Results First Submitted: 2015-05-28
• Results First Submitted QC: 2015-05-28
• Status Verified: 2015-06
• Results First Posted: 2015-06-10
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

• Must be at least 17 and less than 46 years of age
• Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
• Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
• Experiencing moderate to severe pain after extraction of third molars.

Exclusion Criteria

• Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
• Cannot be pregnant (or planning to be pregnant) or nursing a baby
• Unable to swallow whole large tablets or caplets.
• Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen ER	Acetaminophen ER	-
Placebo	Placebo	Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Primary Outcome Measures

Name	Time	Method
Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)	10 Hours	Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.

Secondary Outcome Measures

Name	Time	Method
Time to Confirmed First Perceptible Pain Relief	Within 12 Hours	Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Time to Meaningful Pain Relief	Within 12 Hours	Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
Duration of Pain Relief	Within 12 Hours	Minutes until rescue medication was given.
Patient Global Evaluation	12 Hours	Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.

Trial Locations

Locations (1)

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States