Musculoskeletal PainPhase 1NCT01020279
Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise
A Phase 1 study testing Celecoxib, Ketoprofen and Ketoprofen in people with Musculoskeletal Pain, run by X-pert Med GmbH at 1 site in Germany.
Trial summary
1. Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on muscle pain of the calf caused by eccentric contractions 2. Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions 3. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Celecoxib, Ketoprofen and Ketoprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Jan 2010
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated informed consent prior to participation
- Subjects in good health as determined by the Investigator
- Age 18-55
- Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit)
- For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation
Who cannot join
- Participation in another clinical study within the last 30 days and during the study
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- Pregnancy or lactation
- Alcohol or drug abuse
- Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
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- Skin lesions, dermatological diseases or tattoo in the treatment areas
- Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose
- Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
- Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
- Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
- Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g. Alzheimer's disease or schizophrenia or other psychosis), that in the investigator's opinion may affect efficacy or safety assessments or may compromise subject safety during the study
- Systemic lupus erythematodes, mixed connective tissue disease
- Major heart disease / uncontrollable hypertension
- Peripheral arterial disease and/or cerebrovascular disease
- History of stroke or myocardial infarction
- GFR < 30 ml/min
- ALT and/or AST levels ≥ 5 times the ULN
- Chronic obstructive pulmonary disease including asthma bronchiale
- Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin
- History of pancreatitis or peptic ulcers
- Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
- Reflux esophagitis requiring treatment
- Any other analgesic therapy including cough and cold drugs containing analgesic properties as well as any other substance used for the treatment of pain during the study observation period (Screening to final Visit)
- Any other drug that might alter pain perception like CNS active drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-dose, Randomized, Subject and Observer Blinded, Placebo-controlled, Double-dummy Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise
- Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on muscle pain of the calf caused by eccentric contractions
- Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions
- Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the calf caused by eccentric contractions
- Conditions
- Musculoskeletal Pain
- Being tested
- Celecoxib, Ketoprofen, Ketoprofen
- Keywords
- muscle pain, model
- Medical subject headings
- Musculoskeletal Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib, KetoprofenDrug
Ketoprofen in Transfersome® gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d.
Celecoxib, 200 mg, one capsule b.i.d.
KetoprofenDrug
Placebo gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Oral placebo, one capsule b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Parallel Group A | Other | Celecoxib 200 mg (Active Comparator) ; Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug) Receives: Drug: Celecoxib, Ketoprofen |
| Parallel Group B | Other | oral Placebo (Placebo Comparator); Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug) Receives: Drug: Ketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during muscle contraction
Measured: Day 7
Secondary outcomes (3)
Pain during rest
Measured: Day 7
Surface temperature
Measured: Day 7
Volume of the lower leg
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- X-pert Med GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020279
- Sponsor's protocol ID
- XPM-023
- Status last verified
- Jun 2010
- First submitted
- 9 Nov 2009
- Last updated
- 28 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose, Randomized, Subject and Observer Blinded, Placebo-controlled, Double-dummy Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise
- ClinicalTrials.gov ID
- NCT01020279
- Acronym / sponsor ID
- XPM-023
- Conditions
- Musculoskeletal Pain
- Keywords
- muscle pain, model
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- X-pert Med GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Study completion
- Jan 2010 (actual)
- First posted
- 25 Nov 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.
- Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on muscle pain of the calf caused by eccentric contractions
- Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions
- Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the calf caused by eccentric contractions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parallel Group A | Other | Drug: Celecoxib, KetoprofenCelecoxib 200 mg (Active Comparator) ; Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug) |
| Parallel Group B | Other | Drug: Ketoprofenoral Placebo (Placebo Comparator); Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent prior to participation
- Subjects in good health as determined by the Investigator
- Age 18-55
- Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit)
- For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation
Key exclusion criteria (25 listed)
- Participation in another clinical study within the last 30 days and during the study
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- Pregnancy or lactation
- Alcohol or drug abuse
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 |
|---|---|---|
| Celecoxib, KetoprofenKetoprofen in Transfersome® gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Celecoxib, 200 mg, one capsule b.i.d. | Drug | Parallel Group A |
| KetoprofenPlacebo gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Oral placebo, one capsule b.i.d | Drug | Parallel Group B |
Primary outcome
Pain during muscle contraction
Time frame: Day 7
3 secondary outcomes
Pain during rest
Time frame: Day 7
Surface temperature
Time frame: Day 7
Volume of the lower leg
Time frame: Day 7
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 28 Jun 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib, Ketoprofen and Ketoprofen in people with Musculoskeletal Pain, run by X-pert Med GmbH at 1 site in Germany.
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 25 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 28 Jun 2010. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pain during muscle contraction (time frame: Day 7). 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 28 Jun 2010.