Trial Outcomes & Findings for Acetaminophen (APAP) +/- Oxycodone (NCT NCT04122443)
NCT ID: NCT04122443
Last Updated: 2024-02-28
Results Overview
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
393 participants
Primary outcome timeframe
2 hours following treatment
Results posted on
2024-02-28
Participant Flow
Enrollment into Stage 1 (open label stage) commenced on December 2019 in two urban emergency departments in Bronx, NY. Enrollment was halted from March-June 2020 due to COVID-19, and then resumed and concluded October 2020.
During enrollment into Stage 1 (ibuprofen open label stage), 924 patients were screened for participation and 393 were enrolled. Of the 393, a total of 159 reported insufficient relief of pain from ibuprofen and requested more medication to treat the pain. Five patients who met criteria to progress to the randomized stage withdrew of their own volition. As such, 154 patients progressed to Stage 2. 77 were randomized to oxycodone/acetaminophen and 77 were randomized to acetaminophen alone.
Participant milestones
| Measure |
Acetaminophen
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Oxycodone/Acetaminophen
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
Ibuprofen
Ibuprofen - 600mg PO (Stage 1, Open label)
|
|---|---|---|---|
|
Stage 1 - Open Label
STARTED
|
0
|
0
|
393
|
|
Stage 1 - Open Label
COMPLETED
|
0
|
0
|
154
|
|
Stage 1 - Open Label
NOT COMPLETED
|
0
|
0
|
239
|
|
Stage 2 - Double Blinded
STARTED
|
77
|
77
|
0
|
|
Stage 2 - Double Blinded
COMPLETED
|
77
|
77
|
0
|
|
Stage 2 - Double Blinded
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Acetaminophen
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Oxycodone/Acetaminophen
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
Ibuprofen
Ibuprofen - 600mg PO (Stage 1, Open label)
|
|---|---|---|---|
|
Stage 1 - Open Label
Satisfactory relief after ibuprofen administration. Exited study
|
0
|
0
|
234
|
|
Stage 1 - Open Label
Withdrawal by Subject
|
0
|
0
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ibuprofen + Acetaminophen
n=77 Participants
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen + Oxycodone/Acetaminophen
n=77 Participants
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12 • n=77 Participants
|
38 years
STANDARD_DEVIATION 13 • n=77 Participants
|
37.5 years
STANDARD_DEVIATION 12.5 • n=154 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=77 Participants
|
40 Participants
n=77 Participants
|
76 Participants
n=154 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=77 Participants
|
37 Participants
n=77 Participants
|
78 Participants
n=154 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
77 participants
n=77 Participants
|
77 participants
n=77 Participants
|
393 participants
n=154 Participants
|
|
Pain Assessment
|
8.2 score on a scale
STANDARD_DEVIATION 1.2 • n=77 Participants
|
8.3 score on a scale
STANDARD_DEVIATION 1.3 • n=77 Participants
|
8.3 score on a scale
STANDARD_DEVIATION 1.3 • n=154 Participants
|
PRIMARY outcome
Timeframe: 2 hours following treatmentStage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.
Outcome measures
| Measure |
Ibuprofen and Then Acetaminophen (Stage 2)
n=77 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
n=77 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
|---|---|---|
|
Change in Pain Assessment
|
2.9 score on a scale
Standard Deviation 2.4
|
4.0 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Up to 48 hours following medication administrationStage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Sustained pain relief was determined using a four-item ordinal scale. The rating was verbal and the subject was asked to describe their level of pain within two hours of medication administration and maintaining this level, without rescue medication, for 48 hours. The patients used the following descriptors: severe, moderate, mild, or none. For reporting responses of 'mild' and 'none' were aggregated into a single category and 'moderate' and severe' were aggregated into a separate category.
Outcome measures
| Measure |
Ibuprofen and Then Acetaminophen (Stage 2)
n=77 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
n=77 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
|---|---|---|
|
Sustained Pain Relief
Mild/None
|
33 participants
|
43 participants
|
|
Sustained Pain Relief
Moderate/Severe
|
44 participants
|
34 participants
|
SECONDARY outcome
Timeframe: 2 hours following treatmentPopulation: Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Adequacy of analgesia was determined by querying the participants by asking a single question: "Did the medication provided control your pain?" Answer choices: Yes (it did); No (It did not); and Unsure. The number of participants responses were summarized by category.
Outcome measures
| Measure |
Ibuprofen and Then Acetaminophen (Stage 2)
n=74 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
n=76 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
|---|---|---|
|
Adequacy of Analgesia
Yes
|
51 Participants
|
59 Participants
|
|
Adequacy of Analgesia
No
|
23 Participants
|
17 Participants
|
|
Adequacy of Analgesia
Unsure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 hours following treatmentPopulation: Responses for 4 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating satisfaction with medication was determined by asking participants if the same medication regimen would be desired during a subsequent episode of pain. Possible responses included "Yes", "No" or "Unsure"
Outcome measures
| Measure |
Ibuprofen and Then Acetaminophen (Stage 2)
n=73 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
n=76 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
|---|---|---|
|
Satisfaction With Medication
Yes
|
41 Participants
|
47 Participants
|
|
Satisfaction With Medication
No
|
22 Participants
|
18 Participants
|
|
Satisfaction With Medication
Unsure
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 2 hours following treatmentPopulation: Responses for 3 participants in the 'Acetaminophen' arm and 1 participant in the 'Oxycodone + Acetaminophen' arm were unavailable.
Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): The number of participants demonstrating medication-related adverse events was tabulated by treatment arm/group.
Outcome measures
| Measure |
Ibuprofen and Then Acetaminophen (Stage 2)
n=74 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
n=76 Participants
Ibuprofen - 600mg PO (Stage 1, Open label)
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
|---|---|---|
|
Medication-related Adverse Events
|
7 Participants
|
26 Participants
|
Adverse Events
Ibuprofen and Then Acetaminophen (Stage 2)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Ibuprofen (Stage 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibuprofen and Then Acetaminophen (Stage 2)
n=74 participants at risk
Ibuprofen - 600mg PO (Stage 1, Open label)
Acetaminophen alone (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
|
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
n=76 participants at risk
Ibuprofen - 600mg PO (Stage 1, Open label)
Oxycodone + Acetaminophen (Stage 2, Double blinded)
Acetaminophen: Acetaminophen 650mg PO
Oxycodone: Oxycodone 10mg PO
|
Ibuprofen (Stage 1)
Ibuprofen - 600mg PO (Stage 1, Open label)
|
|---|---|---|---|
|
Nervous system disorders
Dizziness
|
2.7%
2/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
7.9%
6/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
|
Nervous system disorders
Drowsiness
|
8.1%
6/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
22.4%
17/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
6.6%
5/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
|
General disorders
Fatigue
|
0.00%
0/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
1.3%
1/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
0.00%
0/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
1.3%
1/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
1.3%
1/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
|
Nervous system disorders
Shakiness
|
0.00%
0/74 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
1.3%
1/76 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
—
0/0 • Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Up to 2 hours post treatment administration
Stage 1 (Open label) - Patients were not assessed for adverse events Stage 2 (Double blinded) - Adverse event data was unavailable for 3 participants in the 'Acetaminophen' alone arm/group and 1 participant in the 'Oxycodone + Acetaminophen' arm/group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place