Clinical trial NCT02320708: Study of Acetaminophen (ACE) in Post-operative Dental Pain
Official title: A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Keywords: Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Consumer and Personal Products Worldwide
First posted: 2014-12-19
Enrollment: 240
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.


Eligibility criteria: Inclusion Criteria:

1. Are 17 to 50 years of age
2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
3. Dental extraction of three or four third-molars.
4. Experience moderate to severe pain after extraction of third molars

Exclusion Criteria:

1. Currently pregnant (or planning to be pregnant) or nursing a baby
2. Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs (NSAIDs)
3. Inability to swallow whole large tablets or capsules
4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Primary outcomes:
measure: Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)
timeFrame: 6 Hours
Secondary outcomes:
measure: Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)
timeFrame: 4 Hours
measure: Time to meaningful pain relief
timeFrame: Within 6 Hours
measure: Time to first perceptible pain relief
timeFrame: Within 6 Hours
measure: Time to confirmed first perceptible relief
timeFrame: Within 6 Hours
measure: Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)
timeFrame: 4 hours
measure: Time weighted sum of pain relief from 0-6 (TOTPAR 0-6)
timeFrame: 6 hours
measure: Duration of relief after dosing (time to rescue analgesic)
timeFrame: 6 Hours
measure: Proportion of subjects taking a rescue analgesic by 6 hours
timeFrame: 6 Hours
measure: Subject Global Evaluation assessed at hour 6 or at time of rescue
timeFrame: 6 hours
measure: Pain relief (PAR) scores at 0.25 Hours
timeFrame: 0.25 Hours
measure: Pain relief (PAR) scores at 0.5 Hours
timeFrame: 0.5 Hours
measure: Pain relief (PAR) scores at 0.75 Hours
timeFrame: 0.75 Hours
measure: Pain relief (PAR) scores at 1 Hours
timeFrame: 1 Hours
measure: Pain relief (PAR) scores at 1.25 Hours
timeFrame: 1.25 Hours
measure: Pain relief (PAR) scores at 1.5 Hours
timeFrame: 1.5 Hours
measure: Pain relief (PAR) scores at 2 Hours
timeFrame: 2 hoursH
measure: Pain relief (PAR) scores at 3 Hours
timeFrame: 3 Hours
measure: Pain relief (PAR) scores at 4 Hours
timeFrame: 4 Hours
measure: Pain relief (PAR) scores at 5 Hours
timeFrame: 5 Hours
measure: Pain relief (PAR) scores at 6 Hours
timeFrame: 6 Hours
measure: Pain intensity difference (PID) at 0.25 Hours
timeFrame: 0.25 Hours
measure: Pain intensity difference (PID) at 0.5 Hours
timeFrame: 0.5 Hours
measure: Pain intensity difference (PID) at 0.75 Hours
timeFrame: 0.75 Hours
measure: Pain intensity difference (PID) at 1 Hours
timeFrame: 1 Hours
measure: Pain intensity difference (PID) at 1.25 Hours
timeFrame: 1.25 Hours
measure: Pain intensity difference (PID) at 1.5 Hours
timeFrame: 1.5 Hours
measure: Pain intensity difference (PID) at 2 Hours
timeFrame: 2 Hours
measure: Pain intensity difference (PID) at 3 Hours
timeFrame: 3 Hours
measure: Pain intensity difference (PID) at 4 Hours
timeFrame: 4 Hours
measure: Pain intensity difference (PID) at 5 Hours
timeFrame: 5 Hours
measure: Pain intensity difference (PID) at 6 Hours
timeFrame: 6 Hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: