Ankle SprainPhase 4NCT02393846
Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain
A Phase 4 study testing Ketoprofen gel in people with Ankle Sprain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Ketoprofen gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Jun 2015
- 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
- Patient presented with ankle sprain to the emergency department.
- Patients between 18-65 years old.
Who cannot join
- Pain over 24 hours,
- Pain intensity lower than 40 mm,
- allergy to the study drug,
- drug alcohol abuse
- pregnancy or breastfeeding are the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial
The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.
Read the detailed description
Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical in colour, form and smelling. After an eligible patient presented to the ED, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration.
- Conditions
- Ankle Sprain
- Being tested
- Ketoprofen gel, Placebo
- Keywords
- ankle sprain, topical ketoprofen, non-steroidal anti-inflammatory drug, emergency department
- Medical subject headings
- Ankle Injuries, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen gelDrug
Also called Fastjel
Topical ketoprofen as used in gel form.
PlaceboDrug
Also called Placebo gel
Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.
| Study group | Role | What they receive |
|---|---|---|
| ketoprofen | Experimental | Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr. Receives: Drug: Ketoprofen gel |
| Placebo | Placebo comparator | Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.
Measured: 30 minutes
Secondary outcomes (1)
Adverse effects
Adverse effects occurred during the study is recorded to the study form.
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 posted20 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Cenker Eken, Akdeniz University
- Investigators
- Mustafa Serinken, MD, Study chair, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393846
- Sponsor's protocol ID
- PAU2015/05
- Status last verified
- Jul 2015
- First submitted
- 16 Mar 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02393846
- Acronym / sponsor ID
- PAU2015/05
- Conditions
- Ankle Sprain
- Keywords
- ankle sprain, topical ketoprofen, non-steroidal anti-inflammatory drug, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Mar 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.
The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.
Detailed description
Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical in colour, form and smelling. After an eligible patient presented to the ED, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketoprofen | Experimental | Drug: Ketoprofen gelTopical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr. |
| Placebo | Placebo comparator | Drug: PlaceboTopical placebo (gel) is identical in colour, form and smell with the 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)
- Patient presented with ankle sprain to the emergency department.
- Patients between 18-65 years old.
Key exclusion criteria (5 listed)
- Pain over 24 hours,
- Pain intensity lower than 40 mm,
- allergy to the study drug,
- drug alcohol abuse
- pregnancy or breastfeeding are the exclusion criteria.
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 |
|---|---|---|
| Ketoprofen gelAlso: FastjelTopical ketoprofen as used in gel form. | Drug | ketoprofen |
| PlaceboAlso: Placebo gelPlacebo gel which is identical in colour, form and smell compared to ketoprofen gel. | Drug | Placebo |
Primary outcome
Visual analogue scale
Time frame: 30 minutes
Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.
1 secondary outcome
Adverse effects
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 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 gel in people with Ankle Sprain, 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: finished, as of the sponsor's last update on 7 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 7 Jul 2015.