To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )

ClinicalTrials.gov Identifier:

NCT01115673

First received: April 30, 2010

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Results First Received: January 4, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Pain
Interventions:	Drug: Acetaminophen Drug: Placebo Control

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
ACE-1000	1000 mg Acetaminophen Caplet
ACE-650	650 mg Acetaminophen Caplet
ACE-0	0 mg Acetaminophen Caplet

Participant Flow: Overall Study

	ACE-1000	ACE-650	ACE-0
STARTED	239	241	60
COMPLETED	239	241	60
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
ACE-1000	1000 mg Acetaminophen Caplet
ACE-650	650 mg Acetaminophen Caplet
ACE-0	0 mg Acetaminophen Caplet
Total	Total of all reporting groups

Baseline Measures

	ACE-1000	ACE-650	ACE-0	Total
Number of Participants [units: participants]	239	241	60	540
Age [units: years] Mean ± Standard Deviation	18.5 ± 2.24	18.3 ± 1.96	18.1 ± 2.02	18.4 ± 2.09
Gender [units: participants]
Female	131	120	31	282
Male	108	121	29	258
Region of Enrollment [units: participants]
United States	239	241	60	540

Outcome Measures

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1. Primary:

Overall Analgesic Efficacy – Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) [ Time Frame: 6 Hours ]

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2. Secondary:

Sum of Pain Intensity Difference Over Six Hours (SPID6) [ Time Frame: 6 Hours ]

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3. Secondary:

Sum of Pain Relief Scores Over Six Hours (TOTPAR6) [ Time Frame: 6 Hours ]

Show Outcome Measure 3

4. Secondary:

Pain Intensity Difference (PID) at 15 Minutes [ Time Frame: 15 Minutes ]

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5. Secondary:

Pain Intensity Difference (PID) at 30 Minutes [ Time Frame: 30 Minutes ]

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6. Secondary:

Pain Intensity Difference (PID) at 45 Minutes [ Time Frame: 45 Minutes ]

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7. Secondary:

Pain Intensity Difference (PID) at 60 Minutes [ Time Frame: 60 Minutes ]

Show Outcome Measure 7

8. Secondary:

Pain Intensity Difference (PID) at 75 Minutes [ Time Frame: 75 Minutes ]

Show Outcome Measure 8

9. Secondary:

Pain Intensity Difference (PID) at 90 Minutes [ Time Frame: 90 Minutes ]

Show Outcome Measure 9

10. Secondary:

Pain Intensity Difference (PID) at 120 Minutes [ Time Frame: 120 Minutes ]

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11. Secondary:

Pain Intensity Difference (PID) at 180 Minutes [ Time Frame: 180 Minutes ]

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12. Secondary:

Pain Intensity Difference (PID) at 240 Minutes [ Time Frame: 240 Minutes ]

Show Outcome Measure 12

13. Secondary:

Pain Intensity Difference (PID) at 300 Minutes [ Time Frame: 300 Minutes ]

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14. Secondary:

Pain Intensity Difference (PID) at 360 Minutes [ Time Frame: 360 Minutes ]

Show Outcome Measure 14

15. Secondary:

Pain Relief (PAR) Scores at 15 Minutes [ Time Frame: 15 Minutes ]

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16. Secondary:

Pain Relief (PAR) Scores at 30 Minutes [ Time Frame: 30 Minutes ]

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17. Secondary:

Pain Relief (PAR) Scores at 45 Minutes [ Time Frame: 45 Minutes ]

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18. Secondary:

Pain Relief (PAR) Scores at 60 Minutes [ Time Frame: 60 Minutes ]

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19. Secondary:

Pain Relief (PAR) Scores at 75 Minutes [ Time Frame: 75 Minutes ]

Show Outcome Measure 19

20. Secondary:

Pain Relief (PAR) Scores at 90 Minutes [ Time Frame: 90 Minutes ]

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21. Secondary:

Pain Relief (PAR) Scores at 120 Minutes [ Time Frame: 120 Minutes ]

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22. Secondary:

Pain Relief (PAR) Scores at 180 Minutes [ Time Frame: 180 Minutes ]

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23. Secondary:

Pain Relief (PAR) Scores at 240 Minutes [ Time Frame: 240 Minutes ]

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24. Secondary:

Pain Relief (PAR) Scores at 300 Minutes [ Time Frame: 300 Minutes ]

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25. Secondary:

Pain Relief (PAR) Scores at 360 Minutes [ Time Frame: 360 Minutes ]

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Measure Type	Secondary
Measure Title	Pain Relief (PAR) Scores at 360 Minutes
Measure Description	Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Time Frame	360 Minutes
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.

Reporting Groups

	Description
ACE-1000	1000 mg Acetaminophen Caplet
ACE-650	650 mg Acetaminophen Caplet
ACE-0	0 mg Acetaminophen Caplet

Measured Values

	ACE-1000	ACE-650	ACE-0
Number of Participants Analyzed [units: participants]	239	241	60
Pain Relief (PAR) Scores at 360 Minutes [units: units on a scale] Least Squares Mean ± Standard Error	48.0 ± 2.51	36.6 ± 2.50	14.0 ± 5.02

Statistical Analysis 1 for Pain Relief (PAR) Scores at 360 Minutes

Groups ^[1]	ACE-1000 vs. ACE-0
Method ^[2]	ANOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	33.94

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment and baseline pain categorical ratings were factors.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The significance threshold level was 0.05 (two-sided).
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Pain Relief (PAR) Scores at 360 Minutes

Groups ^[1]	ACE-1000 vs. ACE-650
Method ^[2]	ANOVA
P Value ^[3]	0.001
Mean Difference (Final Values) ^[4]	11.40

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment and baseline pain categorical ratings were factors.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The significance threshold level was 0.05 (two-sided).
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Pain Relief (PAR) Scores at 360 Minutes

Groups ^[1]	ACE-650 vs. ACE-0
Method ^[2]	ANOVA
P Value ^[3]	<0.001
Mean Difference (Final Values) ^[4]	22.55

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	Treatment and baseline pain categorical ratings were factors.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The significance threshold level was 0.05 (two-sided).
[4]	Other relevant estimation information:
	No text entered.

26. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes [ Time Frame: 15 Minutes ]

Show Outcome Measure 26

27. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes [ Time Frame: 30 Minutes ]

Show Outcome Measure 27

28. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes [ Time Frame: 45 Minutes ]

Show Outcome Measure 28

29. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes [ Time Frame: 60 Minutes ]

Show Outcome Measure 29

30. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes [ Time Frame: 75 Minutes ]

Show Outcome Measure 30

31. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes [ Time Frame: 90 Minutes ]

Show Outcome Measure 31

32. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes [ Time Frame: 120 Minutes ]

Show Outcome Measure 32

33. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes [ Time Frame: 180 Minutes ]

Show Outcome Measure 33

34. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes [ Time Frame: 240 Minutes ]

Show Outcome Measure 34

35. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes [ Time Frame: 300 Minutes ]

Show Outcome Measure 35

36. Secondary:

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes [ Time Frame: 360 Minutes ]

Show Outcome Measure 36

37. Secondary:

Time to Meaningful Pain Relief [ Time Frame: within 6 Hours ]

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38. Secondary:

Time to Confirmed Perceptible Pain Relief [ Time Frame: within 6 Hours ]

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39. Secondary:

Duration of Analgesia – Time to Rescue [ Time Frame: within 6 Hours ]

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40. Secondary:

Rescue Rates Through Four Hours [ Time Frame: through 4 Hours ]

Show Outcome Measure 40

41. Secondary:

Rescue Rates Through Six Hours [ Time Frame: through 6 Hours ]

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42. Secondary:

Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score [ Time Frame: 6 Hours ]

Show Outcome Measure 42

43. Secondary:

Patient Global Evaluation [ Time Frame: 6 Hours ]

Show Outcome Measure 43

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The results may not be published or referred to at research seminars, lectures or professional meetings, in whole or in part, without the prior written consent of McNeil Consumer Healthcare, to be given or withheld at McNeil Consumer Healthcare’s sole and absolute discretion

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.

Results Point of Contact:

Name/Title: Joyce Hauze, RPS Sr Specialist, Clinical Research Operations
Organization: Johnson & Johnson Consumer and Personal Products Worldwide
phone: 928-277-0715
e-mail: jhauze@its.jnj.com

No publications provided by Johnson & Johnson Consumer and Personal Products Worldwide

Publications automatically indexed to this study:

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.

Responsible Party:	Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier:	NCT01115673 History of Changes
Other Study ID Numbers:	ACEPAI2001
Study First Received:	April 30, 2010
Results First Received:	January 4, 2012
Last Updated:	April 26, 2012
Health Authority:	United States: Food and Drug Administration

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