- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02491879
Ketoprofen Gel vs Placebo in Low Back Pain
December 2, 2015 updated by: Akdeniz University
Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial
This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Mechanical low-back pain which warrants immediate pain relief is not an infrequent symptom for emergency department physicians to deal with.
Parenteral analgesic is the most common drugs for the these patients in emergency department.
However, pain killers in gel forms have not been studied sufficiently for ceasing the pain of these patients.
This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mustafa Serinken, MD
- Phone Number: 00905052991497
- Email: aserinken@hotmail.com
Study Contact Backup
- Name: Cenker Eken, MD
- Phone Number: 00905321593948
- Email: cenkereken@akdeniz.edu.tr
Study Locations
-
-
-
Denizli, Turkey
- Recruiting
- Pamukkale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients over 18 and lower 65 years old
- Patients presented with mechanical low-back pain
Exclusion Criteria:
- Pain more than 24 hours
- Pain lower than with a pain score of 40 mm
- Allergy to ketoprofen
- Drug or alcohol addiction
- pregnancy and breast feeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketoprofen
Ketoprofen gel
|
2.5% Ketoprofen gel with a 2 g local use
Other Names:
|
Placebo Comparator: Placebo
Placebo form of ketoprofen gel
|
Placebo gel with a 2 g local use
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: 30 minutes
|
Pain reduce will be measured by visual analogue scale score at 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse outcome
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
January 1, 2016
Study Completion (Anticipated)
January 1, 2016
Study Registration Dates
First Submitted
July 3, 2015
First Submitted That Met QC Criteria
July 3, 2015
First Posted (Estimate)
July 8, 2015
Study Record Updates
Last Update Posted (Estimate)
December 3, 2015
Last Update Submitted That Met QC Criteria
December 2, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ketoprofen
Other Study ID Numbers
- 24924
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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-
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