Back to resultsComparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Fastjel
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring ketoprofen, gel, low back pain, emergency department
Eligibility Criteria
Inclusion Criteria:
- Mechanical low back pain
Exclusion Criteria:
- Under 18 years old
- Over 65 years old
- Pain less than 40 mm in visual analogue scale
- Allergy to the study drug
- Drug or alcohol addiction
- Pregnancy and lactation
Sites / Locations
- Pamukkale UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketoprofen
Placebo
Arm Description
Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
Placebo arm: placebo gel form of ketoprofen
Outcomes
Primary Outcome Measures
visual analogue scale at 30 minutes
Secondary Outcome Measures
Adverse effects
Full Information
NCT ID
NCT02619695
First Posted
November 30, 2015
Last Updated
December 1, 2015
Sponsor
Akdeniz University
Collaborators
Pamukkale University, Celal Bayar University, Kocatepe University
1. Study Identification
Unique Protocol Identification Number
NCT02619695
Brief Title
Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain
Official Title
Comparison of Ketoprofen Gel to Placebo in Patients Presented With Mechanical Low Back Pain to the Emergency Department: A Randomized Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University
Collaborators
Pamukkale University, Celal Bayar University, Kocatepe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.
Detailed Description
Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (NSAID) and paracetamol are used commonly in these patients. However, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. Gel forms of NSAIDs are used commonly in the outpatient clinics and shown to be effective in these patients by a Cochrane meta-analysis. However, there is no data on the effect of gel forms of analgesics in ED. The application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects.
The present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
ketoprofen, gel, low back pain, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketoprofen
Arm Type
Experimental
Arm Description
Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm: placebo gel form of ketoprofen
Intervention Type
Drug
Intervention Name(s)
Fastjel
Intervention Description
2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
Primary Outcome Measure Information:
Title
visual analogue scale at 30 minutes
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Adverse effects
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mechanical low back pain
Exclusion Criteria:
Under 18 years old
Over 65 years old
Pain less than 40 mm in visual analogue scale
Allergy to the study drug
Drug or alcohol addiction
Pregnancy and lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Serinken, Professor
Email
aserinken@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
aysel ozkan
Email
karek@pau.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, Professor
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken
Email
aserinken@hotmail.com
First Name & Middle Initial & Last Name & Degree
Aysel Ozkan
Email
karek@pau.edu.tr
12. IPD Sharing Statement
Citations:
PubMed Identifier
26501533
Citation
Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/26501533
Description
Pubmed link
Learn more about this trial
Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain
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