Phase 2
N=403
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT01960114 ↗Enrolled (actual)
403
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) — 5.745; 30.986 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acetaminophen ER (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) |
5.745; 30.986 | <0.001 sig |
| SECONDARY Time to Confirmed First Perceptible Pain Relief |
NA; 26.817 | <0.001 sig |
| SECONDARY Time to Meaningful Pain Relief |
NA; 84.675 | <0.001 sig |
| SECONDARY Duration of Pain Relief |
106.5; NA | <0.001 sig |
| SECONDARY Patient Global Evaluation |
63.2; 18.3; 9.0; 11.2; 8.3; 14.6 | 0.001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01960114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.