Mechanical Low Back PainPhase 4NCT02491879
Ketoprofen Gel vs Placebo in Low Back Pain
A Phase 4 study testing Ketoprofen in people with Mechanical Low Back Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Ketoprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 and lower 65 years old
- Patients presented with mechanical low-back pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
Aysel Özkan, 00902582961758, karek@pau.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Ketoprofen, Placebo
- Keywords
- mechanical low back pain, emergency department, ketoprofen, gel
- Medical subject headings
- Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoprofenDrug
Also called Fastjel
2.5% Ketoprofen gel with a 2 g local use
PlaceboOther
Also called normal saline
Placebo gel with a 2 g local use
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen | Experimental | Ketoprofen gel Receives: Drug: Ketoprofen |
| Placebo | Placebo comparator | Placebo form of ketoprofen gel Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain reduce will be measured by visual analogue scale score at 30 minutes
Measured: 30 minutes
Secondary outcomes (1)
Adverse outcome
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Kocatepe University, Manisa Celal Bayar University
- Responsible party
- Sponsor
- Investigators
- Mustafa Serinken, MD, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491879
- Sponsor's protocol ID
- 24924
- Status last verified
- Dec 2015
- First submitted
- 3 Jul 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketoprofen Gel vs Placebo in Patients Presented With Low-back Pain to Emergency Department: A Ranodmized Controlled Trial
- ClinicalTrials.gov ID
- NCT02491879
- Acronym / sponsor ID
- 24924
- Conditions
- Mechanical Low Back Pain
- Keywords
- mechanical low back pain, emergency department, ketoprofen, gel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Kocatepe University, Manisa Celal Bayar University
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 8 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen | Experimental | Drug: KetoprofenKetoprofen gel |
| Placebo | Placebo comparator | Other: PlaceboPlacebo form of ketoprofen gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 and lower 65 years old
- Patients presented with mechanical low-back pain
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetoprofenAlso: Fastjel2.5% Ketoprofen gel with a 2 g local use | Drug | Ketoprofen |
| PlaceboAlso: normal salinePlacebo gel with a 2 g local use | Other | Placebo |
Primary outcome
Visual Analogue Scale
Time frame: 30 minutes
Pain reduce will be measured by visual analogue scale score at 30 minutes
1 secondary outcome
Adverse outcome
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Serinken, MD study chair
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketoprofen in people with Mechanical Low Back Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Serinken, MD (00905052991497, aserinken@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.