Muscle PainPhase 1NCT01271348
Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
A Phase 1 study testing Etoricoxib in people with Muscle Pain, run by X-pert Med GmbH at 1 site in Germany.
Trial summary
Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric contractions Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Pain
- What is being tested?
- Etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Oct 2011
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 18-40 or 50-70
- BMI > 20 and < 30
- Pain in the target muscle (thigh) during muscle contraction of at least 5 on an 11 point categorical pain rating scale
- Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study treatment periods (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 not allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are 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
Show all 25Show fewer
- Known hypersensitivity to etoricoxib or other NSAID´s including Cox-2, or any of their excipients
- Bronchospasm, acute rhinitis, nasal congestion, angioneurotic edema, urticaria or allergic reactions after taking aspirin or other NSAIDs including Cox-2 inhibitors
- Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal 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. depressive disorders, Alzheimer's disease, schizophrenia or other psychosis), that in the investigator's opinion may affect efficacy or safety assessments or may compromise subject safety during the study
- Heart failure (NYHA II-IV)
- Long term blood pressure > 140/90 mm Hg without adequate treatment
- Peripheral arterial disease, coronary heart disease and/or cerebrovascular disease
- History of stroke or myocardial infarction
- Clinically relevant ECG changes
- Estimated creatinine clearance < 60 ml/min
- Liver dysfunction (e.g. defined by ALT and/or AST levels above upper limit of normal range)
- Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin
- History of pancreatitis, peptic ulcers or gastrointestinal bleedings
- Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
- 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
- Statins within 3 months of screening and throughout the study
- Oral anticonceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-dose, Randomized, Double Blinded, Placebo-controlled, Cross Over Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
Comparison of the effect of etoricoxib to placebo on muscle pain caused by eccentric contractions
- Conditions
- Muscle Pain
- Being tested
- Etoricoxib, placebo
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Etoricoxib film tablet, 90 mg, q.d.
placeboDrug
Placebo tablet, q.d.
| Study group | Role | What they receive |
|---|---|---|
| Etoricoxib | Active comparator | Not described Receives: Drug: Etoricoxib |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during muscle contraction
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- X-pert Med GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Rother, M.D., Study chair, Director Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271348
- Sponsor's protocol ID
- XPM-032
- Status last verified
- Oct 2011
- First submitted
- 5 Jan 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose, Randomized, Double Blinded, Placebo-controlled, Cross Over Study of Etoricoxib for the Treatment of Muscle Pain and Inflammation Induced by Eccentric Exercise
- ClinicalTrials.gov ID
- NCT01271348
- Acronym / sponsor ID
- XPM-032
- Conditions
- Muscle Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- X-pert Med GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 Jan 2011 (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 etoricoxib to placebo on muscle pain caused by eccentric contractions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoricoxib | Active comparator | Drug: Etoricoxib |
| Placebo tablet | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent prior to participation
- Subjects in good health as determined by the Investigator
- Age 18-40 or 50-70
- BMI > 20 and < 30
- Pain in the target muscle (thigh) during muscle contraction of at least 5 on an 11 point categorical pain rating scale
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 |
|---|---|---|
| EtoricoxibEtoricoxib film tablet, 90 mg, q.d. | Drug | Etoricoxib |
| placeboPlacebo tablet, q.d. | Drug | Placebo tablet |
Primary outcome
Pain during muscle contraction
Time frame: 7 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 1 Nov 2011.
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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.
Matthias Rother, M.D. study chair
Director Clinical Operations
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 Etoricoxib in people with Muscle 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 7 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 1 Nov 2011. 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. 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 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: 7 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 1 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.