Trial Outcomes & Findings for Adult Oral Ibuprofen Study for ED Pain Patients (NCT NCT03441269)
NCT ID: NCT03441269
Last Updated: 2020-06-04
Results Overview
Difference in mean pain scores among all groups from at 60 minutes from baseline; negative difference infers decrease in pain score. A pain score of 10 indicates severe pain, 5 indicates moderate pain and 0 indicates no pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
225 participants
Primary outcome timeframe
60 minutes
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
400mg/Dose
Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
600mg/Dose
Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
800mg/Dose
Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
75
|
|
Overall Study
COMPLETED
|
75
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
400mg/Dose
n=75 Participants
Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
600mg/Dose
n=75 Participants
Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
800mg/Dose
n=75 Participants
Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 16.2 • n=75 Participants
|
45.6 years
STANDARD_DEVIATION 15.8 • n=75 Participants
|
42.6 years
STANDARD_DEVIATION 15.9 • n=75 Participants
|
44.4 years
STANDARD_DEVIATION 15.9 • n=225 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=75 Participants
|
44 Participants
n=75 Participants
|
28 Participants
n=75 Participants
|
111 Participants
n=225 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=75 Participants
|
31 Participants
n=75 Participants
|
47 Participants
n=75 Participants
|
114 Participants
n=225 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
75 participants
n=75 Participants
|
75 participants
n=75 Participants
|
75 participants
n=75 Participants
|
225 participants
n=225 Participants
|
PRIMARY outcome
Timeframe: 60 minutesDifference in mean pain scores among all groups from at 60 minutes from baseline; negative difference infers decrease in pain score. A pain score of 10 indicates severe pain, 5 indicates moderate pain and 0 indicates no pain.
Outcome measures
| Measure |
400mg/Dose
n=75 Participants
Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
600mg/Dose
n=74 Participants
Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
800mg/Dose
n=74 Participants
Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
|---|---|---|---|
|
Pain Reduction at 60 Minutes From Baseline of the 3 Oral Ibuprofen Groups
|
-2.12 units on a scale
Interval -2.45 to -1.8
|
-1.85 units on a scale
Interval -2.05 to -1.66
|
-1.96 units on a scale
Interval -2.18 to -1.74
|
SECONDARY outcome
Timeframe: 60 minutesRates of Adverse Event of the 3 Oral Ibuprofen Dosage Groups
Outcome measures
| Measure |
400mg/Dose
n=75 Participants
Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
600mg/Dose
n=74 Participants
Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
800mg/Dose
n=74 Participants
Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
|---|---|---|---|
|
Rates of Adverse Event of the 3 Oral Ibuprofen Dosage Groups
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 60 minutesRates of Requiring Rescue Analgesia for pain management
Outcome measures
| Measure |
400mg/Dose
n=75 Participants
Oral Ibuprofen dose of 400mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
600mg/Dose
n=74 Participants
Oral Ibuprofen dose of 600mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
800mg/Dose
n=74 Participants
Oral Ibuprofen dose of 800mg/dose for mild to moderate acute pain in ED patients.
Oral Ibuprofen: Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
|
|---|---|---|---|
|
Rates of Requiring Rescue Analgesia
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
400mg/Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
600mg/Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
800mg/Dose
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