Clinical trial NCT01115673: To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 540
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

Detailed description: This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.

Eligibility criteria: Inclusion Criteria:

* Must be at least 16 and less than 51 years of age
* Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
* Must have up to four of their back teeth (third-molars) pulled

Exclusion Criteria:

* Cannot be allergic to acetaminophen (Tylenol)
* Cannot be pregnant (or planning to be pregnant) or nursing a baby
* Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results

Primary outcomes:
measure: Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
timeFrame: 6 Hours
Secondary outcomes:
measure: Sum of Pain Intensity Difference Over Six Hours (SPID6)
timeFrame: 6 Hours
measure: Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
timeFrame: 6 Hours
measure: Pain Intensity Difference (PID) at 15 Minutes
timeFrame: 15 Minutes
measure: Pain Intensity Difference (PID) at 30 Minutes
timeFrame: 30 Minutes
measure: Pain Intensity Difference (PID) at 45 Minutes
timeFrame: 45 Minutes
measure: Pain Intensity Difference (PID) at 60 Minutes
timeFrame: 60 Minutes
measure: Pain Intensity Difference (PID) at 75 Minutes
timeFrame: 75 Minutes
measure: Pain Intensity Difference (PID) at 90 Minutes
timeFrame: 90 Minutes
measure: Pain Intensity Difference (PID) at 120 Minutes
timeFrame: 120 Minutes
measure: Pain Intensity Difference (PID) at 180 Minutes
timeFrame: 180 Minutes
measure: Pain Intensity Difference (PID) at 240 Minutes
timeFrame: 240 Minutes
measure: Pain Intensity Difference (PID) at 300 Minutes
timeFrame: 300 Minutes
measure: Pain Intensity Difference (PID) at 360 Minutes
timeFrame: 360 Minutes
measure: Pain Relief (PAR) Scores at 15 Minutes
timeFrame: 15 Minutes
measure: Pain Relief (PAR) Scores at 30 Minutes
timeFrame: 30 Minutes
measure: Pain Relief (PAR) Scores at 45 Minutes
timeFrame: 45 Minutes
measure: Pain Relief (PAR) Scores at 60 Minutes
timeFrame: 60 Minutes
measure: Pain Relief (PAR) Scores at 75 Minutes
timeFrame: 75 Minutes
measure: Pain Relief (PAR) Scores at 90 Minutes
timeFrame: 90 Minutes
measure: Pain Relief (PAR) Scores at 120 Minutes
timeFrame: 120 Minutes
measure: Pain Relief (PAR) Scores at 180 Minutes
timeFrame: 180 Minutes
measure: Pain Relief (PAR) Scores at 240 Minutes
timeFrame: 240 Minutes
measure: Pain Relief (PAR) Scores at 300 Minutes
timeFrame: 300 Minutes
measure: Pain Relief (PAR) Scores at 360 Minutes
timeFrame: 360 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
timeFrame: 15 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
timeFrame: 30 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
timeFrame: 45 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
timeFrame: 60 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
timeFrame: 75 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
timeFrame: 90 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
timeFrame: 120 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
timeFrame: 180 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
timeFrame: 240 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
timeFrame: 300 Minutes
measure: Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
timeFrame: 360 Minutes
measure: Time to Meaningful Pain Relief
timeFrame: within 6 Hours
measure: Time to Confirmed Perceptible Pain Relief
timeFrame: within 6 Hours
measure: Duration of Analgesia - Time to Rescue
timeFrame: within 6 Hours
measure: Rescue Rates Through Four Hours
timeFrame: through 4 Hours
measure: Rescue Rates Through Six Hours
timeFrame: through 6 Hours
measure: Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
timeFrame: 6 Hours
measure: Patient Global Evaluation
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: Daniel Qi, M.D.
role: STUDY_DIRECTOR
References:
citation: Qi DS, May LG, Zimmerman B, Peng P, Atillasoy E, Brown JD, Cooper SA. A randomized, double-blind, placebo-controlled study of acetaminophen 1000 mg versus acetaminophen 650 mg for the treatment of postsurgical dental pain. Clin Ther. 2012 Dec;34(12):2247-2258.e3. doi: 10.1016/j.clinthera.2012.11.003. Epub 2012 Nov 28.