Hydrocodone Compared to Acetaminophen and Ibuprofen for P... | NCT05544734

Hydrocodone Compared to Acetaminophen and Ibuprofen for P... | NCT05544734 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hydrocodone 5mg/acetaminophen 325mg	Active Comparator	Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days	Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab Drug: Acetaminophen 1000mg Drug: Ibuprofen 400 mg
Acetaminophen 1000mg + Ibuprofen 400mg	Active Comparator	Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days	Drug: Acetaminophen 1000mg Drug: Ibuprofen 400 mg

Name	Type	Description	Arm Group Labels	Other Names
Hydrocodone 5Mg/Acetaminophen 325Mg Tab	Drug	5 mg/325 mg tablet	Hydrocodone 5mg/acetaminophen 325mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale	Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.	Baseline, 2 days

Secondary Outcomes

Measure	Description	Time Frame
Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire	Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120).

Contacts/Locations Module

Name	Affiliation	Role
Shari Lipner, MD, PhD	Weill Medical College of Cornell University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Weill Medical College of Cornell University		New York	New York	10021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37619705	Derived	Hwang JK, Ricardo JW, Lipner SR. Combination of acetaminophen and ibuprofen is noninferior to acetaminophen and hydrocodone for postnail procedure analgesia: A randomized controlled trial. J Am Acad Dermatol. 2023 Dec;89(6):1300-1302. doi: 10.1016/j.jaad.2023.08.042. Epub 2023 Aug 22. No abstract available.

Arm/Group Information

ID	Title	Description
FG000	Hydrocodone 5mg/Acetaminophen 325mg	Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet
FG001	Acetaminophen 1000mg + Ibuprofen 400mg	Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00010 subjects FG00110 subjects
COMPLETED		FG00010 subjects FG00110 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Hydrocodone 5mg/Acetaminophen 325mg	Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

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

Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale

Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 2 days

ID	Title	Description
OG000	Hydrocodone 5mg/Acetaminophen 325mg	Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet
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	Hydrocodone 5mg/Acetaminophen 325mg	Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr Shari Lipner	Weill Cornell Medicine	6469623376		shl9032@med.cornell.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 15, 2022	Aug 22, 2023	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D009260	Nail Diseases
D009264	Nails, Malformed
D000377	Agnosia

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D006853	Hydrocodone
D000082	Acetaminophen
C083640	acetaminophen, hydrocodone drug combination
C514822	oxycodone-acetaminophen
D007052	Ibuprofen

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG0002 BG0012 BG0024
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0001 BG0012 BG0023
White	BG0007 BG0016 BG00213
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0000 BG0010 BG0020

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		t-test, 2 sided		0.69		Median Difference (Final Values)	-0.30			2-Sided	95	-1.85	1.25			Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).		Superiority

Secondary

Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire

Change in health-related quality of life associated with pain obtained with an adapted version of the APS-POQ-R (APS Patient Outcome Questionnaire) between the 2 groups on postoperative days 3 and 6. The APS-POQ-R is a questionnaire used for rating health-related quality of life associated with pain, with scores of each domain ranging from 0 to 10 or 0% to 100%, and higher scores indicating greater severity of impact on quality of life (12 domains summed up for total score range of minimum 0 to maximum 120).

Posted

Mean

Standard Deviation

score on a scale

3 days, 6 days (end of study)

ID	Title	Description
OG000	Hydrocodone 5mg/Acetaminophen 325mg	Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days Hydrocodone 5Mg/Acetaminophen 325Mg Tab: 5 mg/325 mg tablet Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet
OG001	Acetaminophen 1000mg + Ibuprofen 400mg	Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days Acetaminophen 1000mg: 1000 mg tablet Ibuprofen 400 mg: 400 mg tablet

Units	Counts
Participants	OG00010 OG00110

Title

Denominators