Tendonitis of the Shoulder, Elbow, or KneePhase 2KTPNCT00903994
A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee
A Phase 2 study testing Ketoprofen Topical Patch 20% in people with Tendonitis of the Shoulder, Elbow, or Knee, run by APR Applied Pharma Research s.a. at 2 sites in United States.
Trial summary
Open-label study to be conducted at 2 US investigational sites in subjects who have acute tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment with the KTP, applied once daily at the same application site for 3 consecutive days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendonitis of the Shoulder, Elbow, or Knee
- What is being tested?
- Ketoprofen Topical Patch 20%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Aug 2007
- Phase
- Phase 2
- 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
- Are males or females 18 years of age or older (If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all females are considered to be of childbearing potential unless they are post-menopausal, biologically sterile, or surgically sterile (i.e., hysterectomy, bilateral oophorectomy), or have undergone tubal ligation for greater than or equal to one year.)
- Have a diagnosis of acute tendonitis or bursitis of the shoulder, elbow or knee with acute onset of the current episode in the 15 days preceding the screening visit
- Have average pain intensity during daily activities over the past 24 hours rated 5 or greater on an 11-point scale (range 0 to 10). (If the onset of acute tendonitis or bursitis is less than 24 hours before the screening visit, the patient will rate the average pain intensity during daily activity since the time of onset.) Site personnel must not reveal this eligibility criterion to prospective patients.
- Are willing to discontinue use of all analgesic medications (including over-the-counter [OTC] analgesics) except the study patch. Note: Aspirin at a daily dose of 81 mg per day for cardiovascular prophylaxis will be allowed.
- Have been informed of the nature of the study and have provided written informed consent
Who cannot join
- Have a positive urine pregnancy test (females of childbearing potential only) or are pregnant or lactating
- Have tendonitis or bursitis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis, spondyloarthropathies), or resulting from calcification or requiring surgery
- Have had pharmacologic treatment (e.g., analgesic medications except 81mg prophylactic aspirin) less than 12 hours before the baseline assessments
- Have received systemic corticosteroids in the 30 days preceding the screening visit (e.g., intra-articular, peritendinous, oral, or parenteral administration). Nasal inhalation steroids are permitted.
- Have received any pharmacologic treatment or physical therapy in the past 6 months for the joint targeted for this study. Pharmacologic treatment or physical therapy for current tendonitis or bursitis is allowed unless the medication or therapy is prohibited by the protocol.
- Require continued use of an immobilization device for treatment of the current episode of tendonitis or bursitis
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- Have a history or physical examination finding that is incompatible with safe participation in the study, including GI ulcer or bleeding, anemia or prolonged bleeding time
- Have a history, or physical examination finding, that is incompatible with study product use or with obtaining robustly interpretable data, chronic skin conditions such as psoriasis, clinically significant osteoarthritis, or skin lesions or wounds at the affected site
- Have a history of drug or alcohol abuse
- Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. This includes:
- patients with allergies to prescription or OTC products containing NSAIDs
- patients in whom aspirin or other NSAIDs or analgesic drugs induce the syndrome of asthma, rhinitis and nasal polyps
- patients taking medications that may affect clotting, for example warfarin, parenteral heparin, ticlopidine (Ticlid®) or clopidogrel (Plavix®)
- patients taking lithium
- patients taking methotrexate
- Are renally or hepatically impaired in the judgment of the investigator based on the patient's medical history or other available clinical laboratory information
- Are taking sleep medications, muscle relaxants, anticonvulsants or antidepressants at a dose that has not been stable for at least 3 months
- Receiving physical therapy for the tendonitis/bursitis. Ongoing, stable physical therapy for conditions not related to tendonitis/bursitis is allowed.
- Have scheduled elective surgery or other invasive procedures during the period of study participation
- Have any illness or concurrent condition that would, in the opinion of the investigator or medical monitor, make study participation unsafe or would confound study results (e.g.,inflammatory arthritis, spondyloarthropathies, fibromyalgia, or are currently undergoing treatment for chronic pain)
- Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HOPE Research Institute, LLC
Phoenix, Arizona, 85050
CPI, Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: An Open-Label, Phase II, Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee
Open-label study to be conducted at 2 US investigational sites in subjects who have acute tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment with the KTP, applied once daily at the same application site for 3 consecutive days.
- Being tested
- Ketoprofen Topical Patch 20%
- Keywords
- Acute Pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen Topical Patch 20%Drug
Ketoprofen is a pressure-sensitive adhesive material containing 20% Ketoprofen which is applied to a polyester textile and covered with a foil release liner.for the treatment of mild to moderate acute pain associated with Tendonitis or Bursitis of the shoulder, elbow or knee
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single Arm Receives: Drug: Ketoprofen Topical Patch 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the time to onset of action of the KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow, or knee as measured by the time to meaningful pain relief.
Measured: 3 consecutive days
Secondary outcomes (3)
Assess the safety and tolerability of the KTP as measured by adverse events cutaneous AEs, assessments of local tolerability and patch adherence, and vital signs
Measured: 3 consecutive days
Assess the time to first perceptible pain relief
Measured: 3 consecutive days
Assess the effect of KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow or knee as measured by pain intensity during activity and pain relief.
Measured: 3 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startJun 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendonitis of the Shoulder, Elbow, or KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- APR Applied Pharma Research s.a.
- Sponsor type
- University, hospital or other
- Investigators
- Study Director, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903994
- Sponsor's protocol ID
- EN3269-201
- Other IDs
- Ketoprofen Topical Patch, 20%
- Acronym
- KTP
- Status last verified
- Feb 2020
- First submitted
- 15 May 2009
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase II, Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee
- ClinicalTrials.gov ID
- NCT00903994
- Acronym / sponsor ID
- KTP / EN3269-201
- Keywords
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- APR Applied Pharma Research s.a.University, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 19 May 2009 (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.
Open-label study to be conducted at 2 US investigational sites in subjects who have acute tendonitis or bursitis of the shoulder, elbow, or knee. Eligible subjects receive treatment with the KTP, applied once daily at the same application site for 3 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: Ketoprofen Topical Patch 20%Single Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are males or females 18 years of age or older (If female, must be practicing abstinence or using a medically acceptable form of contraception (e.g., intrauterine device, hormonal birth control, or double barrier method). For the purpose of this study, all females are considered to be of childbearing potential unless they are post-menopausal, biologically sterile, or surgically sterile (i.e., hysterectomy, bilateral oophorectomy), or have undergone tubal ligation for greater than or equal to one year.)
- Have a diagnosis of acute tendonitis or bursitis of the shoulder, elbow or knee with acute onset of the current episode in the 15 days preceding the screening visit
- Have average pain intensity during daily activities over the past 24 hours rated 5 or greater on an 11-point scale (range 0 to 10). (If the onset of acute tendonitis or bursitis is less than 24 hours before the screening visit, the patient will rate the average pain intensity during daily activity since the time of onset.) Site personnel must not reveal this eligibility criterion to prospective patients.
- Are willing to discontinue use of all analgesic medications (including over-the-counter [OTC] analgesics) except the study patch. Note: Aspirin at a daily dose of 81 mg per day for cardiovascular prophylaxis will be allowed.
- Have been informed of the nature of the study and have provided written informed consent
Key exclusion criteria (21 listed)
- Have a positive urine pregnancy test (females of childbearing potential only) or are pregnant or lactating
- Have tendonitis or bursitis secondary to a systemic inflammatory disease (e.g., rheumatoid arthritis, spondyloarthropathies), or resulting from calcification or requiring surgery
- Have had pharmacologic treatment (e.g., analgesic medications except 81mg prophylactic aspirin) less than 12 hours before the baseline assessments
- Have received systemic corticosteroids in the 30 days preceding the screening visit (e.g., intra-articular, peritendinous, oral, or parenteral administration). Nasal inhalation steroids are permitted.
- Have received any pharmacologic treatment or physical therapy in the past 6 months for the joint targeted for this study. Pharmacologic treatment or physical therapy for current tendonitis or bursitis is allowed unless the medication or therapy is prohibited by the protocol.
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%Ketoprofen is a pressure-sensitive adhesive material containing 20% Ketoprofen which is applied to a polyester textile and covered with a foil release liner.for the treatment of mild to moderate acute pain associated with Tendonitis or Bursitis of the shoulder, elbow or knee | Drug | Single Arm |
Primary outcome
To measure the time to onset of action of the KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow, or knee as measured by the time to meaningful pain relief.
Time frame: 3 consecutive days
3 secondary outcomes
Assess the safety and tolerability of the KTP as measured by adverse events cutaneous AEs, assessments of local tolerability and patch adherence, and vital signs
Time frame: 3 consecutive days
Assess the time to first perceptible pain relief
Time frame: 3 consecutive days
Assess the effect of KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow or knee as measured by pain intensity during activity and pain relief.
Time frame: 3 consecutive days
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 18 Feb 2020.
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.
Study Director study director
Endo USA Inc., a Keenova Therapeutics Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketoprofen Topical Patch 20% in people with Tendonitis of the Shoulder, Elbow, or Knee, run by APR Applied Pharma Research s.a. at 2 sites 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 5 inclusion and 21 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To measure the time to onset of action of the KTP in the treatment of pain associated with acute tendonitis or bursitis of the shoulder, elbow, or knee as measured by the time to meaningful pain relief. (time frame: 3 consecutive days). 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 18 Feb 2020.