Study of Long-Acting Acetaminophen in Postoperative Denta... | NCT01960114

Study of Long-Acting Acetaminophen in Postoperative Denta... | NCT01960114 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acetaminophen ER	Experimental		Drug: Acetaminophen ER
Placebo	Placebo Comparator	Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Acetaminophen ER	Drug	Single dose (2 tablets) Acetaminophen ER 750 mg	Acetaminophen ER

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)	Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.	10 Hours

Secondary Outcomes

Measure	Description	Time Frame
Time to Confirmed First Perceptible Pain Relief	Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.

Contacts/Locations Module

Name	Affiliation	Role
McNeil Study Director	McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jean Brown Research		Salt Lake City	Utah	84124	United States

ID	Title	Description
FG000	Placebo	Placebo (two matching placebo tablets)
FG001	ACE ER 1500 mg	Acetaminophen ER 1500 mg (two 750 mg ER tablets)

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000134 subjects FG001269 subjects
COMPLETED		FG000133 subjects FG001268 subjects
NOT COMPLETED		FG0001 subjects FG0011 subjects

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects
Could not swallow study medication		FG0000 subjects FG001

Baseline Characteristics Module

ID	Title	Description
BG000	Placebo	Placebo (two matching placebo tablets)
BG001	ACE ER 1500 mg	Acetaminophen ER 1500 mg (two 750 mg ER tablets)

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)

Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.

Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Posted

Least Squares Mean

Standard Error

units on a scale

10 Hours

ID	Title	Description
OG000	Placebo	Placebo (two matching placebo tablets)
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo (two matching placebo tablets)

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 16.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Rajesh Mishra, MD, PhD/Vice President, Medical/Clinical Affairs, Global OTC	McNeil Consumer Healthcare	215-273-8569 USA EST		rmishr16@its.jnj.com

Condition Browse Module

ID	Term
D014098	Toothache
D010149	Pain, Postoperative

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D005157	Facial Pain
D010146	Pain

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.	ANOVA	Treatment and baseline pain categorical score were factors.	<0.001	The significance threshold level was 0.05 (two-sided).	Least Squares Mean Difference	25.241	Standard Error of the Mean	2.8344	2-Sided	95	19.669	30.813				No	Superiority or Other

Secondary

Time to Confirmed First Perceptible Pain Relief

Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.

Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Posted

Median

95% Confidence Interval

Minutes

Within 12 Hours

ID	Title	Description
OG000	Placebo	Placebo (two matching placebo tablets)
OG001	ACE ER 1500 mg	Acetaminophen ER 1500 mg (two 750 mg ER tablets)

Units	Counts
Participants	OG000134 OG001268

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Data for the placebo group are not available. Median and 95% Confidence Interval were not estimable because fewer than 50% of the subjects treated with Placebo obtained perceptible pain relief. OG00126.817(23.683 to 29.950)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.	Wilcoxon test, from SAS PROC LIFETEST		<0.001	The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.					2-Sided							No	Superiority or Other

Secondary

Time to Meaningful Pain Relief

Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.

Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Posted

Median

95% Confidence Interval

Minutes

Within 12 Hours

ID	Title	Description
OG000	Placebo	Placebo (two matching placebo tablets)
OG001	ACE ER 1500 mg	Acetaminophen ER 1500 mg (two 750 mg ER tablets)

Units	Counts
Participants	OG000134 OG001268

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Data for the placebo group are not available. Median and 95% Confidence Interval were not estimable because fewer than 50% of the subjects treated with Placebo obtained meaningful pain relief. OG00184.675(66.333 to 120.633)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.	Wilcoxon test, from SAS PROC LIFETEST		<0.001	The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.					2-Sided							No	Superiority or Other

Secondary

Duration of Pain Relief

Minutes until rescue medication was given.

Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Posted

Median

95% Confidence Interval

Minutes

Within 12 Hours

ID	Title	Description
OG000	Placebo	Placebo (two matching placebo tablets)
OG001	ACE ER 1500 mg	Acetaminophen ER 1500 mg (two 750 mg ER tablets)

Units	Counts
Participants	OG000134 OG001268

Title

Denominators

Categories

Title	Measurements
	OG000106.5(99.000 to 132.000) OG001NA(NA to NA)Data for the acetaminophen ER 1500 mg group are not available. Median and 95% Confidence Interval were not estimable since fewer than 50% of the subjects treated with acetaminophen ER 1500 mg rescued.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.	Log Rank		<0.001	The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.					2-Sided							No	Superiority or Other

Secondary

Patient Global Evaluation

Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.

Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Posted

Number

percentage of participants

12 Hours

ID	Title	Description
OG000	Placebo	Placebo (two matching placebo tablets)
OG001	ACE ER 1500 mg	Acetaminophen ER 1500 mg (two 750 mg ER tablets)

Units	Counts
Participants	OG000133 OG001268

Title

Denominators

Categories

Poor (0)

Title	Measurements
	OG00063.2 OG00118.3

Fair (1)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.	Cochran-Mantel-Haenszel	Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.	0.001	The significance threshold level was 0.05 (two-sided).					2-Sided							No	Superiority or Other