Study of Long-Acting Acetaminophen in Postoperative Dental Pain

Dental Pain Clinical Trial

Official title:

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960114
• Other study ID #: AERPAI2001
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2013
• Last updated: June 11, 2015
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

Drug:
• Acetaminophen ER
Single dose (2 tablets) Acetaminophen ER 750 mg
• Placebo
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)	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.	10 Hours	No
Secondary	Time to Confirmed First Perceptible Pain Relief	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.	Within 12 Hours	No
Secondary	Time to Meaningful Pain Relief	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.	Within 12 Hours	No
Secondary	Duration of Pain Relief	Minutes until rescue medication was given.	Within 12 Hours	No
Secondary	Patient Global Evaluation	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.	12 Hours	No