TendonitisPhase 3NCT00426985
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
A Phase 3 study testing Ketoprofen Topical Patch 20% in people with Tendonitis and Bursitis, 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 tendonitis or bursitis of the shoulder, elbow or knee Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendonitis, Bursitis
- What is being tested?
- Ketoprofen Topical Patch 20%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2007to 10 Mar 2008
- 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 tendonitis or bursitis of the shoulder, elbow or knee
- Meet pain entry criteria
- Willing to discontinue use of any pain medication not provided by study
Who cannot join
- Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
- 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 Tendonitis or Bursitis of the Shoulder, Elbow or Knee
The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with tendonitis or bursitis of the shoulder, elbow or knee
Read the detailed description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), 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. The use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.
- Conditions
- Tendonitis, Bursitis
- Being tested
- Ketoprofen Topical Patch 20%, Placebo
- Keywords
- Tendonitis, Bursitis, Pain, Shoulder Pain, Elbow Pain, Knee Pain, Tendon Injury, Muscle, Bone and Cartilage Disorders
- Medical subject headings
- Tendinopathy, Bursitis, Pain, Shoulder Pain, Tendon Injuries, 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
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofene | Experimental | Not described Receives: Drug: Ketoprofen Topical Patch 20% |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
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; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2007 (estimated)
- Study start7 Feb 2007
- Primary completion10 Mar 2008
- Study completion10 Mar 2008
Why it stopped: Sponsor (Endo Pharmaceuticals) decision (business reasons)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendonitisStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkemira SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PPD, Study director, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426985
- Sponsor's protocol ID
- EN3269-304
- Status last verified
- Aug 2008
- First submitted
- 24 Jan 2007
- Last updated
- 30 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 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 Tendonitis or Bursitis of the Shoulder, Elbow or Knee
- ClinicalTrials.gov ID
- NCT00426985
- Acronym / sponsor ID
- EN3269-304
- Conditions
- Tendonitis, Bursitis
- Keywords
- Tendonitis, Bursitis, Pain, Shoulder Pain, Elbow Pain, Knee Pain, Tendon Injury, Muscle, Bone and Cartilage Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor (Endo Pharmaceuticals) decision (business reasons)
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Alkemira SAIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2007 (actual)
- Primary completion
- 10 Mar 2008 (actual)
- Study completion
- 10 Mar 2008 (actual)
- First posted
- 26 Jan 2007 (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 tendonitis or bursitis of the shoulder, elbow or knee
Detailed description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with tendonitis or bursitis of the shoulder, elbow or knee. Eligible patients will have tendonitis or bursitis or the shoulder, elbow or knee and will be randomized (1:1 ratio) to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 21 days. Patients will return to the clinic for assessments on Day 3, Day 7, Day 14 and Day 21; a follow-up assessment will be conducted by telephone on Day 35. At each visit through Day 21, patients will rate their average pain intensity during daily activities and while at rest using the 11-point scale (range 0 to 10), 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. The use of study treatment and rescue medication will be recorded in the diary each day. Ibuprofen will be provided as prn rescue medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofene | Experimental | Drug: Ketoprofen Topical Patch 20% |
| Placebo | Placebo comparator | Other: Placebo |
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 tendonitis or bursitis of the shoulder, elbow or knee
- Meet pain entry criteria
- Willing to discontinue use of any pain medication not provided by study
Key exclusion criteria (6 listed)
- Have tendonitis or bursitis secondary to a systemic inflammatory disease, calcification or requiring surgery
- 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 | Ketoprofene |
| Placebo | Other | Placebo |
Primary outcome
Average pain intensity during daily activities
1 secondary outcome
Average pain intensity while at rest; use of prn rescue medication; patient's and physician's global assessments of study medication, MPI, Sleep
Results and safety
The study was stopped early (reason given: Sponsor (Endo Pharmaceuticals) decision (business reasons)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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 study director
PPD Development, LP
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 Tendonitis and Bursitis, 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: stopped early, as of the sponsor's last update on 30 Sep 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. 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 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 was stopped early (reason given: Sponsor (Endo Pharmaceuticals) decision (business reasons)). Results are not available in the source record.
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 30 Sep 2026.