HealthyPhase 1NCT02183077
Pharmacokinetics and Tolerability of Meloxicam Gel Compared to Meloxicam Tablets in Healthy Subjects
A Phase 1 study testing Meloxicam gel and Meloxicam tablet in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meloxicam gel and Meloxicam tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Nov 1998
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
- Age >= 18 and <= 50 years
- Broca >= -20% and <= + 20 %
Who cannot join
- Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
- Hypersensitivity to meloxicam and any of the excipients or non-steroidal antirheumatic agents
Show all 25Show fewer
- Intake of drugs with a long half-life (>24 hours) (<= 1 month prior to administration or during the trial)
- Use of any drugs which might influence the results of the trial (<= 10 days prior to administration or during the trial)
- Participation in another trial with an investigational drug (<= 2 months prior to administration or during the trial)
- Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
- Inability to refrain from smoking on study days
- Known alcohol abuse
- Known drug abuse
- Blood donation (<= 1 months prior to administration)
- Excessive physical activities (<= 5 days prior to administration)
- History of hemorrhagic diatheses
- History of gastrointestinal ulcer, perforation or bleeding
- History of bronchial asthma
- Any laboratory value outside the normal range of clinical relevance
- History of dermatological diseases
- Skin disease and/or skin lesions at the site of planned application
- For female subjects:
- Pregnancy
- Positive pregnancy test
- Breast feeding
About this study
Official title: Pharmacokinetics and Tolerability of 2 x 15 mg Meloxicam (2 x 0.3 g Topical Gel) Over 7 Days Compared to 7.5 mg Meloxicam Tablet (Single Oral Dose) in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study
Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.
- Conditions
- Healthy
- Being tested
- Meloxicam gel, Meloxicam tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam gelDrug
Meloxicam tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam gel | Experimental | Not described Receives: Drug: Meloxicam gel |
| Meloxicam tablet | Active comparator | Not described Receives: Drug: Meloxicam tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of plasma concentration-time course after topical dose
Measured: up to 264 hours after first topical administration
Determination of the ratio AUCss topical/AUC0-∞ oral
Measured: up to 96 hours after oral administration
Secondary outcomes (18)
Maximum measured concentration of the analyte in plasma (Cmax)
Measured: up to 96 hours after oral administration
Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
Measured: up to 96 hours after oral administration
Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)
Measured: up to 96 hours after oral administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 96 hours after oral administration
Terminal half-life of the analyte in plasma (t½)
Measured: up to 96 hours after oral administration
Apparent terminal elimination rate constant
Measured: up to 96 hours after oral administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Measured: up to 96 hours after oral administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/F)
Measured: up to 96 hours after oral administration
Mean residence time (MRTtot)
Measured: up to 96 hours after oral administration
Excretion of metabolites in urine
Measured: 0-24 hours after oral administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: up to 264 hours after first topical administration
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: up to 264 hours after first topical administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Measured: up to 264 hours after first topical administration
Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss)
Measured: up to 264 hours after first topical administration
Terminal half-life of the analyte in plasma (t½)
Measured: up to 264 hours after first topical administration
Apparent terminal elimination rate constant
Measured: up to 264 hours after first topical administration
Occurence of adverse events
Measured: up to 24 days
Assessment of local and systemic tolerability
Measured: up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startSep 1998
- Primary completionNov 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183077
- Sponsor's protocol ID
- 107.214
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Tolerability of 2 x 15 mg Meloxicam (2 x 0.3 g Topical Gel) Over 7 Days Compared to 7.5 mg Meloxicam Tablet (Single Oral Dose) in Healthy Subjects. A Two-way Cross-over, Randomized, Open Study
- ClinicalTrials.gov ID
- NCT02183077
- Acronym / sponsor ID
- 107.214
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 1998
- Primary completion
- Nov 1998 (actual)
- First posted
- 8 Jul 2014 (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.
Study to gain information on the percutaneous absorption of meloxicam after administration of a topical gel over 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam gel | Experimental | Drug: Meloxicam gel |
| Meloxicam tablet | Active comparator | Drug: Meloxicam tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by results of screening
- Signed written informed consent in accordance with Good Clinical Practice and local legislation
- Age >= 18 and <= 50 years
- Broca >= -20% and <= + 20 %
Key exclusion criteria (25 listed)
- Any findings of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
- Chronic or relevant acute infections
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 |
|---|---|---|
| Meloxicam gel | Drug | Meloxicam gel |
| Meloxicam tablet | Drug | Meloxicam tablet |
Primary outcome
Analysis of plasma concentration-time course after topical dose
Time frame: up to 264 hours after first topical administration
Determination of the ratio AUCss topical/AUC0-∞ oral
Time frame: up to 96 hours after oral administration
18 secondary outcomes
Maximum measured concentration of the analyte in plasma (Cmax)
Time frame: up to 96 hours after oral administration
Time from dosing to the maximum concentration of the analyte in plasma (Tmax)
Time frame: up to 96 hours after oral administration
Total area under the plasma drug concentration time curve (AUC) from time of administration to the time of the last quantifiable drug concentration (AUC0-t)
Time frame: up to 96 hours after oral administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 96 hours after oral administration
Terminal half-life of the analyte in plasma (t½)
Time frame: up to 96 hours after oral administration
Apparent terminal elimination rate constant
Time frame: up to 96 hours after oral administration
Apparent clearance of the analyte in plasma following extravascular administration (CL/F)
Time frame: up to 96 hours after oral administration
Apparent volume of distribution of the analyte during the terminal phase (Vz/F)
Time frame: up to 96 hours after oral administration
Mean residence time (MRTtot)
Time frame: up to 96 hours after oral administration
Excretion of metabolites in urine
Time frame: 0-24 hours after oral administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: up to 264 hours after first topical administration
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 264 hours after first topical administration
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
Time frame: up to 264 hours after first topical administration
Total area under the plasma drug concentration time curve (AUC) during a steady state interval (AUCss)
Time frame: up to 264 hours after first topical administration
Terminal half-life of the analyte in plasma (t½)
Time frame: up to 264 hours after first topical administration
Apparent terminal elimination rate constant
Time frame: up to 264 hours after first topical administration
Occurence of adverse events
Time frame: up to 24 days
Assessment of local and systemic tolerability
Time frame: up to 24 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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Meloxicam gel and Meloxicam tablet in people with Healthy, run by Boehringer Ingelheim.
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 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Analysis of plasma concentration-time course after topical dose (time frame: up to 264 hours after first topical administration). The study lists 2 primary outcomes in all. 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 8 Jul 2014.