MedDataX Logo

Ketoprofen Gel vs Placebo in Low Back Pain

NCT ID: NCT02491879

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketoprofen

Ketoprofen gel

Group Type EXPERIMENTAL

Ketoprofen

Intervention Type DRUG

2.5% Ketoprofen gel with a 2 g local use

Placebo

Placebo form of ketoprofen gel

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo gel with a 2 g local use

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketoprofen

2.5% Ketoprofen gel with a 2 g local use

Intervention Type DRUG

Placebo

Placebo gel with a 2 g local use

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fastjel normal saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kocatepe University

OTHER

Sponsor Role collaborator

Celal Bayar University

OTHER

Sponsor Role collaborator

Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mustafa Serinken, MD

Role: STUDY_CHAIR

Pamukkale University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mustafa Serinken, MD

Role: CONTACT

[email protected]
00905052991497

Cenker Eken, MD

Role: CONTACT

[email protected]
00905321593948

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aysel Özkan

Role: primary

[email protected]
00902582961758

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24924

Identifier Type: -

Identifier Source: org_study_id