Trial Outcomes & Findings for Comparative Efficacy of 4 Oral Analgesics (NCT NCT02455518)
NCT ID: NCT02455518
Last Updated: 2018-02-13
Results Overview
Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
416 participants
Primary outcome timeframe
2 hours
Results posted on
2018-02-13
Participant Flow
Participant milestones
| Measure |
Oxycodone/Acetaminophen
Oxycodone/acetaminophen (5 mg/325 mg)
Oxycodone/acetaminophen
|
Hydrocodone/Acetaminophen
Hydrocodone/acetaminophen (5 mg/300 mg)
Hydrocodone/acetaminophen
|
Codeine/Acetaminophen
Codeine/acetaminophen (30 mg/300 mg)
Codeine/acetaminophen
|
Ibuprofen/Acetaminophen
Ibuprofen/acetaminophen (400 mg/1000 mg)
Ibuprofen/acetaminophen
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
104
|
104
|
|
Overall Study
COMPLETED
|
104
|
103
|
103
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Oxycodone/Acetaminophen
Oxycodone/acetaminophen (5 mg/325 mg)
Oxycodone/acetaminophen
|
Hydrocodone/Acetaminophen
Hydrocodone/acetaminophen (5 mg/300 mg)
Hydrocodone/acetaminophen
|
Codeine/Acetaminophen
Codeine/acetaminophen (30 mg/300 mg)
Codeine/acetaminophen
|
Ibuprofen/Acetaminophen
Ibuprofen/acetaminophen (400 mg/1000 mg)
Ibuprofen/acetaminophen
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
3
|
Baseline Characteristics
Comparative Efficacy of 4 Oral Analgesics
Baseline characteristics by cohort
| Measure |
Oxycodone/Acetaminophen
n=104 Participants
Oxycodone/acetaminophen (5 mg/325 mg)
Oxycodone/acetaminophen
|
Hydrocodone/Acetaminophen
n=103 Participants
Hydrocodone/acetaminophen (5 mg/300 mg)
Hydrocodone/acetaminophen
|
Codeine/Acetaminophen
n=103 Participants
Codeine/acetaminophen (30 mg/300 mg)
Codeine/acetaminophen
|
Ibuprofen/Acetaminophen
n=101 Participants
Ibuprofen/acetaminophen (400 mg/1000 mg)
Ibuprofen/acetaminophen
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12 • n=5 Participants
|
37 years
STANDARD_DEVIATION 13 • n=7 Participants
|
37 years
STANDARD_DEVIATION 12 • n=5 Participants
|
37 years
STANDARD_DEVIATION 11 • n=4 Participants
|
37 years
STANDARD_DEVIATION 12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
199 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Latino
|
62 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African-American
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
East Asian/Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=5 Participants
|
103 participants
n=7 Participants
|
103 participants
n=5 Participants
|
101 participants
n=4 Participants
|
411 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 hoursChange in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Outcome measures
| Measure |
Oxycodone/Acetaminophen
n=104 Participants
Oxycodone/acetaminophen (5 mg/325 mg)
Oxycodone/acetaminophen
|
Hydrocodone/Acetaminophen
n=103 Participants
Hydrocodone/acetaminophen (5 mg/300 mg)
Hydrocodone/acetaminophen
|
Codeine/Acetaminophen
n=103 Participants
Codeine/acetaminophen (30 mg/300 mg)
Codeine/acetaminophen
|
Ibuprofen/Acetaminophen
n=101 Participants
Ibuprofen/acetaminophen (400 mg/1000 mg)
Ibuprofen/acetaminophen
|
|---|---|---|---|---|
|
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
|
4.4 units on a scale
Interval 3.7 to 5.0
|
3.5 units on a scale
Interval 2.9 to 4.2
|
3.9 units on a scale
Interval 3.2 to 4.5
|
4.3 units on a scale
Interval 3.6 to 4.9
|
SECONDARY outcome
Timeframe: 1 hourChange in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)
Outcome measures
| Measure |
Oxycodone/Acetaminophen
n=104 Participants
Oxycodone/acetaminophen (5 mg/325 mg)
Oxycodone/acetaminophen
|
Hydrocodone/Acetaminophen
n=103 Participants
Hydrocodone/acetaminophen (5 mg/300 mg)
Hydrocodone/acetaminophen
|
Codeine/Acetaminophen
n=103 Participants
Codeine/acetaminophen (30 mg/300 mg)
Codeine/acetaminophen
|
Ibuprofen/Acetaminophen
n=101 Participants
Ibuprofen/acetaminophen (400 mg/1000 mg)
Ibuprofen/acetaminophen
|
|---|---|---|---|---|
|
Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
|
3.1 units on a scale
Interval 2.6 to 3.7
|
2.4 units on a scale
Interval 1.8 to 3.0
|
2.7 units on a scale
Interval 2.1 to 3.3
|
2.9 units on a scale
Interval 2.4 to 3.5
|
Adverse Events
Oxycodone/Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrocodone/Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Codeine/Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen/Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place