SprainPhase 3NCT00351104
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain
A Phase 3 study testing Ketoprofen Topical Patch 20% in people with Sprain and Strain, run by Alkemira SA at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ketoprofen Topical Patch 20%
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2007
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 years of age or older
- Diagnosis of Grade I or Grade II ankle sprain or strain
- Meet pain entry criteria
- Willing to discontinue use of any pain medication not provided as part of the study
Who cannot join
- Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
- Have received corticosteroids in the 30 days preceding screening
- Have a history or physical examination finding that is incompatible with safe participation in the study
- Have a history or physical examination finding that is incompatible with study product use
- Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
- Are taking medications that may significantly affect renal function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Grade 1 or Grade 2 Ankle Sprain or Strain
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
Read the detailed description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with Grade 1 or Grade 2 ankle sprains or strains. Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted by telephone on Day 28. At each visit through Day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as rescue medication
- Being tested
- Ketoprofen Topical Patch 20%
- Keywords
- Sprain, Strain, Pain, Ankle Pain, Muscle, Bone and Cartilage Disorders
- Medical subject headings
- Sprains and Strains, Pain, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen Topical Patch 20%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity during daily activities
Secondary outcomes (1)
Average pain intensity while at rest; Functional disability; Use of rescue medication; Quality of sleep; Patient's and physician's global assessments of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SprainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkemira SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PPD, Principal investigator, PPD Austin, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351104
- Sponsor's protocol ID
- EN3269-301
- Status last verified
- Feb 2020
- First submitted
- 30 Jun 2006
- Last updated
- 1 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase III Study of the Efficacy, Tolerability and Safety of Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Grade 1 or Grade 2 Ankle Sprain or Strain
- ClinicalTrials.gov ID
- NCT00351104
- Acronym / sponsor ID
- EN3269-301
- Keywords
- Sprain, Strain, Pain, Ankle Pain, Muscle, Bone and Cartilage Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alkemira SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Jul 2006 (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 purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
Detailed description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with Grade 1 or Grade 2 ankle sprains or strains. Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days. Patients will return to the clinic for assessments on Day 3, Day 7 and Day 14; a follow-up assessment will be conducted by telephone on Day 28. At each visit through Day 14, patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale, and will rate their functional disability. Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as rescue medication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females 18 years of age or older
- Diagnosis of Grade I or Grade II ankle sprain or strain
- Meet pain entry criteria
- Willing to discontinue use of any pain medication not provided as part of the study
Key exclusion criteria (6 listed)
- Have a Grade 3 sprain or Grade 3 strain, bilateral sprain or strain, or concomitant fracture or wound at the site of the sprain or strain.
- Have received corticosteroids in the 30 days preceding screening
- Have a history or physical examination finding that is incompatible with safe participation in the study
- Have a history or physical examination finding that is incompatible with study product use
- Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
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 Topical Patch 20% | Drug | – |
Primary outcome
Average pain intensity during daily activities
1 secondary outcome
Average pain intensity while at rest; Functional disability; Use of rescue medication; Quality of sleep; Patient's and physician's global assessments of study medication
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 1 Oct 2026.
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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.
PPD principal investigator
PPD Austin, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketoprofen Topical Patch 20% in people with Sprain and Strain, run by Alkemira SA at 1 site in United States.
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 4 inclusion and 6 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 1 Oct 2026. 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 United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Average pain intensity during daily activities. 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 1 Oct 2026.