Trial Outcomes & Findings for Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial (NCT NCT00790270)
NCT ID: NCT00790270
Last Updated: 2012-11-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Daily for 1 week
Results posted on
2012-11-21
Participant Flow
Participant milestones
| Measure |
Cyclobenzaprine
|
Ibuprofen
|
Ibuprophen Plus Cyclobenzaprine
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
20
|
|
Overall Study
COMPLETED
|
21
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
Cyclobenzaprine
n=21 Participants
|
Ibuprofen
n=20 Participants
|
Ibuprophen Plus Cyclobenzaprine
n=20 Participants
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age Continuous
|
36 years
STANDARD_DEVIATION 13 • n=5 Participants
|
32 years
STANDARD_DEVIATION 10 • n=7 Participants
|
32 years
STANDARD_DEVIATION 10 • n=5 Participants
|
33 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
61 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Daily for 1 weekOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursPopulation: number of patients using additionl anlagesics on the day following enrollment
the number of patients taking additional rescue medications beyond the study meds
Outcome measures
| Measure |
Cyclobenzaprine
n=21 Participants
|
Ibuprofen
n=20 Participants
|
Ibuprophen Plus Cyclobenzaprine
n=20 Participants
|
|---|---|---|---|
|
Use of Rescue Medications
|
13 participants
|
9 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 1 weekOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: next daynumber of patients resuming regular activity the day following enrollment.
Outcome measures
| Measure |
Cyclobenzaprine
n=21 Participants
|
Ibuprofen
n=20 Participants
|
Ibuprophen Plus Cyclobenzaprine
n=20 Participants
|
|---|---|---|---|
|
Resumption of Work or School
|
8 participants
|
14 participants
|
13 participants
|
Adverse Events
Cyclobenzaprine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprofen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ibuprophen Plus Cyclobenzaprine
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