NCT02491879

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

July 3, 2015

Last Update Submit

December 2, 2015

Conditions

Mechanical Low Back Pain

Keywords

mechanical low back painemergency departmentketoprofengel

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Pain reduce will be measured by visual analogue scale score at 30 minutes

    30 minutes

Secondary Outcomes (1)

  • Adverse outcome

    30 minutes

Study Arms (2)

Ketoprofen

EXPERIMENTAL

Ketoprofen gel

Drug: Ketoprofen

Placebo

PLACEBO COMPARATOR

Placebo form of ketoprofen gel

Other: Placebo

Interventions

KetoprofenDRUG

2.5% Ketoprofen gel with a 2 g local use

Also known as: Fastjel
Ketoprofen
PlaceboOTHER

Placebo gel with a 2 g local use

Also known as: normal saline
Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients over 18 and lower 65 years old
  • Patients presented with mechanical low-back pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back PainEmergencies

Interventions

KetoprofenSaline Solution

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mustafa Serinken, MD

    Pamukkale University

    STUDY CHAIR

Central Study Contacts

Mustafa Serinken, MD

CONTACT

00905052991497aserinken@hotmail.com

Cenker Eken, MD

CONTACT

00905321593948cenkereken@akdeniz.edu.tr

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

July 3, 2015

First Posted

July 8, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

TU(1)