Phase 3
N=540
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01115673 ↗Enrolled (actual)
540
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) — 529.4; 427.3; 60.0 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Acetaminophen (Drug); Placebo Control (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) |
529.4; 427.3; 60.0 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference Over Six Hours (SPID6) |
222.5; 174.3; -4.2 | <0.001 sig |
| SECONDARY Sum of Pain Relief Scores Over Six Hours (TOTPAR6) |
306.9; 253.0; 64.3 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 15 Minutes |
5.6; 6.9; 1.3 | 0.037 sig |
| SECONDARY Pain Intensity Difference (PID) at 30 Minutes |
21.3; 21.5; 0.5 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 45 Minutes |
33.9; 32.8; 0.2 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 60 Minutes |
40.4; 36.6; -0.1 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 75 Minutes |
43.1; 37.6; -0.9 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 90 Minutes |
44.4; 38.0; -0.6 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 120 Minutes |
44.8; 35.7; -2.7 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 180 Minutes |
40.8; 31.9; -2.6 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 240 Minutes |
40.8; 30.3; -1.1 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 300 Minutes |
37.9; 27.1; -0.1 | <0.001 sig |
| SECONDARY Pain Intensity Difference (PID) at 360 Minutes |
33.4; 23.8; 1.0 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 15 Minutes |
8.3; 9.4; 3.0 | 0.028 sig |
| SECONDARY Pain Relief (PAR) Scores at 30 Minutes |
29.6; 29.9; 4.8 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 45 Minutes |
46.1; 44.8; 7.9 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 60 Minutes |
54.4; 50.1; 8.3 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 75 Minutes |
58.0; 52.0; 8.4 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 90 Minutes |
59.9; 53.1; 10.1 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 120 Minutes |
60.3; 50.8; 8.0 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 180 Minutes |
56.3; 46.3; 9.5 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 240 Minutes |
56.2; 44.3; 12.3 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 300 Minutes |
52.2; 40.5; 13.8 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 360 Minutes |
48.0; 36.6; 14.0 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes |
13.9; 16.4; 4.2 | 0.027 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes |
50.9; 51.3; 5.2 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes |
80.0; 77.6; 8.1 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes |
94.9; 86.7; 8.2 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes |
101.1; 89.6; 7.4 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes |
104.2; 91.2; 9.4 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes |
105.1; 86.5; 5.3 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes |
97.1; 78.2; 6.9 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes |
97.0; 74.6; 11.2 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes |
90.1; 67.6; 13.7 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes |
81.4; 60.4; 15.0 | <0.001 sig |
| SECONDARY Time to Meaningful Pain Relief |
53.7; 56.1; NA | <0.001 sig |
| SECONDARY Time to Confirmed Perceptible Pain Relief |
22.2; 22.2; NA | <0.001 sig |
| SECONDARY Duration of Analgesia - Time to Rescue |
NA; NA; 99.5 | <0.001 sig |
| SECONDARY Rescue Rates Through Four Hours |
20.1; 32.4; 80.0 | <0.001 sig |
| SECONDARY Rescue Rates Through Six Hours |
29.3; 45.6; 80.0 | <0.001 sig |
| SECONDARY Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score |
56.9; 44.4; 6.7 | <0.001 sig |
| SECONDARY Patient Global Evaluation |
2.28; 1.95; 0.60 | <0.001 sig |
Summary
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
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
Data sourced from ClinicalTrials.gov (NCT01115673). 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.