NCT00790270

Brief Summary

The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

November 21, 2012

Completed
Last Updated

November 21, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

November 12, 2008

Results QC Date

October 19, 2009

Last Update Submit

October 22, 2012

Conditions

Cervical Strain

Keywords

Cervical strainwhiplashibuprofencyclobenzaprine

Outcome Measures

Primary Outcomes (2)

  • Pain

    Daily for 1 week

  • Use of Rescue Medications

    the number of patients taking additional rescue medications beyond the study meds

    24 hours

Secondary Outcomes (2)

  • Time to Resumption of Work

    1 week

  • Resumption of Work or School

    next day

Study Arms (3)

Cyclobenzaprine

ACTIVE COMPARATOR
Drug: Cyclobenzaprine

Ibuprofen

ACTIVE COMPARATOR
Drug: Ibuprofen

Ibuprophen plus Cyclobenzaprine

EXPERIMENTAL
Drug: Ibuprofen plus Cyclobenzaprine

Interventions

CyclobenzaprineDRUG

5 mg orally every 8 hours as needed

Also known as: flexeril
Cyclobenzaprine
IbuprofenDRUG

Ibuprofen 400 mg every 8 hours as needed

Also known as: motrin, advil
Ibuprofen
Ibuprofen plus CyclobenzaprineDRUG

Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed

Also known as: motrin or advil with flexeril
Ibuprophen plus Cyclobenzaprine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • neck pain within 24 hours of injury

You may not qualify if:

  • Children, allergy or contraindication to any of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11733, United States

Location

MeSH Terms

Conditions

Whiplash Injuries

Interventions

cyclobenzaprineIbuprofen

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Adam Singer
Organization
Stony Brook U
adam.singer@stonybrook.edu
631 444 7856

Study Officials

  • adam singer, md

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

January 1, 2003

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

November 21, 2012

Results First Posted

November 21, 2012

Record last verified: 2012-10

Locations

US(1)