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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02491879
Other study ID # 24924
Secondary ID
Status Recruiting
Phase Phase 4
First received July 3, 2015
Last updated December 2, 2015
Start date June 2015
Est. completion date January 2016

Study information

Verified date December 2015
Source Akdeniz University
Contact Mustafa Serinken, MD
Phone 00905052991497
Email aserinken@hotmail.com
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Interventional

Clinical Trial Summary

This study aimed to analyse the analgesic effect of ketoprofen gel in patients presented with mechanical low-back pain to the emergency department.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketoprofen
2.5% Ketoprofen gel with a 2 g local use
Other:
Placebo
Placebo gel with a 2 g local use

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (3)

Lead Sponsor Collaborator
Akdeniz University Celal Bayar University, Kocatepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale Pain reduce will be measured by visual analogue scale score at 30 minutes 30 minutes No
Secondary Adverse outcome 30 minutes Yes
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