Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 low-back-pain
Started Jun 2015
Shorter than P25 for phase_4 low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedDecember 2, 2015
November 1, 2015
7 months
November 30, 2015
December 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analogue scale at 30 minutes
30 minutes
Secondary Outcomes (1)
Adverse effects
30 minutes
Study Arms (2)
Ketoprofen
EXPERIMENTALInterventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
Placebo
PLACEBO COMPARATORPlacebo arm: placebo gel form of ketoprofen
Interventions
Eligibility Criteria
You may qualify if:
- Mechanical low back pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akdeniz Universitylead
- Pamukkale Universitycollaborator
- Celal Bayar Universitycollaborator
- Kocatepe Universitycollaborator
Study Sites (1)
Pamukkale University
Denizli, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 26501533BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mustafa Serinken, Professor
Pamukkale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 2, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
December 2, 2015
Record last verified: 2015-11