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Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT00790270
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : November 21, 2012
Last Update Posted : November 21, 2012
Sponsor:
Information provided by:
Stony Brook University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cervical Strain
Interventions Drug: Cyclobenzaprine
Drug: Ibuprofen
Drug: Ibuprofen plus Cyclobenzaprine
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 21 20 20
Completed 21 20 20
Not Completed 0 0 0
Arm/Group Title Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 21 20 20 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 20 participants 61 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
20
 100.0%
20
 100.0%
61
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 20 participants 20 participants 61 participants
36  (13) 32  (10) 32  (10) 33  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 20 participants 61 participants
Female
14
  66.7%
11
  55.0%
9
  45.0%
34
  55.7%
Male
7
  33.3%
9
  45.0%
11
  55.0%
27
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 20 participants 61 participants
21 20 20 61
1.Primary Outcome
Title Pain
Hide Description [Not Specified]
Time Frame Daily for 1 week
Outcome Measure Data Not Reported
2.Primary Outcome
Title Use of Rescue Medications
Hide Description the number of patients taking additional rescue medications beyond the study meds
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
number of patients using additionl anlagesics on the day following enrollment
Arm/Group Title Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 20 20
Measure Type: Number
Unit of Measure: participants
13 9 9
3.Secondary Outcome
Title Time to Resumption of Work
Hide Description [Not Specified]
Time Frame 1 week
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Resumption of Work or School
Hide Description number of patients resuming regular activity the day following enrollment.
Time Frame next day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 20 20
Measure Type: Number
Unit of Measure: participants
8 14 13
Time Frame next day
Adverse Event Reporting Description th number of patients reporting an adverse event on the day following enrollment and each additional day for 1 week.
 
Arm/Group Title Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cyclobenzaprine Ibuprofen Ibuprophen Plus Cyclobenzaprine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Adam Singer
Organization: Stony Brook U
Phone: 631 444 7856
Responsible Party: Adam Singer, MD, Stony Brook University
ClinicalTrials.gov Identifier: NCT00790270     History of Changes
Other Study ID Numbers: SB2003-1234
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: October 19, 2009
Results First Posted: November 21, 2012
Last Update Posted: November 21, 2012