HealthyPhase 4NCT02183155
Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects
A Phase 4 study testing Meloxicam - low, Meloxicam - medium and Meloxicam - high in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an active control to assess trial sensitivity on bleeding time in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Meloxicam - low, Meloxicam - medium and Meloxicam - high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Sep 2000
- Phase
- Phase 4
- 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
- Healthy male or female subjects between the ages of 18 and 55 years
- Negative urine pregnancy test on Day1 for females of childbearing potential
- Weight within +/- 20 percent of ideal weight according to the Metropolitan Life Height and Weight chart
- Willing and able to cooperate with the investigator and his/her staff
- Written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Who cannot join
- Any finding, medical condition or dietary restriction that, in the investigator's opinion, may interfere with optimal participation in the study or produce a significant risk to the subject
- In the opinion of the investigator, the subject has any disease or condition that may result in altered absorption, excess accumulation, or impaired metabolism or excretion of the trial medications
- A known or suspected hypersensitivity to any of the trial medications or their excipients or any other NSAIDs (Non-Steroid Anti-Inflammatory Drug)
- A history of gastrointestinal ulcer, perforation or bleeding
- A history of cerebrovascular bleeding or any other bleeding disorder
- Women of childbearing potential not using adequate contraception (e.g, intrauterine device, contraceptive pills, Depo-Provera® implant, barrier device) for at least 3 months prior to, and for the duration of trial participation. It should be noted that NSAIDs may interfere with the effectiveness of intrauterine devices
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- History of bronchial asthma
- Use of any medications that might influence the results of the trial
- Use of anticoagulants, including warfarin, heparin, ticlopidine, clopidogrel or aspirin
- Any laboratory value outside the normal range that is considered clinically significant by the investigator. In addition, subjects with the following specific laboratory values will not be allowed:
- A serum creatinine concentration at baseline > 1.5 mg/dl
- SGOT (serum glutamic-oxaloacetic transaminase) or SGPT (serum glutamic-pyruvic transaminase) liver enzymes results at baseline > 1.5 times the upper limit of normal
- A hemoglobin concentration < 10.5 g/dl
- A white cell count < 3500/mm³
- A platelet < 100,000/mm³ or a documented abnormal bleeding time, platelet aggregation, thromboxane B2 synthesis, thromboplastin time (PT) or activated partial thromboplastin time (APTT)
- Inability to refrain from smoking on testing days
- Participation in another trial with an investigational drug within 30 days of entering the trial
- Subjects with increased keloid formation
- Previous surgery of the gastrointestinal tract (except appendectomy)
- Participation in excessive physical activities (≤ 5 days prior to administration)
- Current drug or alcohol abuse
- Small or difficult to locate arm veins that would impair the clinician's ability to draw blood samples
- Homeopathic medication
About this study
Official title: A Double Blind, Randomized, Parallel Group Trial to Compare the Effect of Three Doses of Meloxicam Tablets (7.5, 15 and 30 mg) With Placebo on Bleeding Time in Healthy Subjects; With Extended-release Indomethacin Capsules 75 mg (Open-label) as an Active Control to Assess Trial Sensitivity.
The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an active control to assess trial sensitivity on bleeding time in healthy subjects. The secondary aim of this study was to assess effects of treatment on other platelet function and coagulation parameters.
- Conditions
- Healthy
- Being tested
- Meloxicam - low, Meloxicam - medium, Meloxicam - high, Placebo, Extended-release indomethacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam - lowDrug
Meloxicam - mediumDrug
Meloxicam - highDrug
PlaceboDrug
Extended-release indomethacinDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam - low | Experimental | Not described Receives: Drug: Meloxicam - low |
| Meloxicam - medium | Experimental | Not described Receives: Drug: Meloxicam - medium |
| Meloxicam - high | Experimental | Not described Receives: Drug: Meloxicam - high |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Extended-release indomethacin | Active comparator | Not described Receives: Drug: Extended-release indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in bleeding time
Measured: up to 6 hours post-dose at day 8
Secondary outcomes (9)
Change from baseline in platelet aggregation
Measured: up to 6 hours post-dose at day 8
Change from baseline in Platelet thromboxane B2 synthesis (TXB2 synthesis)
Measured: up to 6 hours post-dose at day 8
Change in Thromboplastin Time (PT)
Measured: up to 6 hours post-dose at day 8
Change in Activated Partial Thromboplastin Time (APTT)
Measured: up to 6 hours post-dose at day 8
Change in Platelet Count
Measured: up to 6 hours post-dose at day 8
Change in Leucocyte Activation
Measured: Day 1 and 6 hours post-dose at day 8
Plasma levels of meloxicam
Measured: pre-dose, 3 and 6 hours post-dose at day 8
Plasma levels of indomethacin
Measured: pre-dose, 3 and 6 hours post-dose at day 8
Number of patients with adverse events
Measured: up to 8 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 startMay 2000
- Primary completionSep 2000
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 82 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
- NCT02183155
- Sponsor's protocol ID
- 107.236
- 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
- A Double Blind, Randomized, Parallel Group Trial to Compare the Effect of Three Doses of Meloxicam Tablets (7.5, 15 and 30 mg) With Placebo on Bleeding Time in Healthy Subjects; With Extended-release Indomethacin Capsules 75 mg (Open-label) as an Active Control to Assess Trial Sensitivity.
- ClinicalTrials.gov ID
- NCT02183155
- Acronym / sponsor ID
- 107.236
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Sep 2000 (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.
The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an active control to assess trial sensitivity on bleeding time in healthy subjects. The secondary aim of this study was to assess effects of treatment on other platelet function and coagulation parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Meloxicam - low | Experimental | Drug: Meloxicam - low |
| Meloxicam - medium | Experimental | Drug: Meloxicam - medium |
| Meloxicam - high | Experimental | Drug: Meloxicam - high |
| Placebo | Placebo comparator | Drug: Placebo |
| Extended-release indomethacin | Active comparator | Drug: Extended-release indomethacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects between the ages of 18 and 55 years
- Negative urine pregnancy test on Day1 for females of childbearing potential
- Weight within +/- 20 percent of ideal weight according to the Metropolitan Life Height and Weight chart
- Willing and able to cooperate with the investigator and his/her staff
- Written informed consent in accordance with GCP (Good Clinical Practice) and local legislation
Key exclusion criteria (23 listed)
- Any finding, medical condition or dietary restriction that, in the investigator's opinion, may interfere with optimal participation in the study or produce a significant risk to the subject
- In the opinion of the investigator, the subject has any disease or condition that may result in altered absorption, excess accumulation, or impaired metabolism or excretion of the trial medications
- A known or suspected hypersensitivity to any of the trial medications or their excipients or any other NSAIDs (Non-Steroid Anti-Inflammatory Drug)
- A history of gastrointestinal ulcer, perforation or bleeding
- A history of cerebrovascular bleeding or any other bleeding disorder
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 - low | Drug | Meloxicam - low |
| Meloxicam - medium | Drug | Meloxicam - medium |
| Meloxicam - high | Drug | Meloxicam - high |
| Placebo | Drug | Placebo |
| Extended-release indomethacin | Drug | Extended-release indomethacin |
Primary outcome
Change from baseline in bleeding time
Time frame: up to 6 hours post-dose at day 8
9 secondary outcomes
Change from baseline in platelet aggregation
Time frame: up to 6 hours post-dose at day 8
Change from baseline in Platelet thromboxane B2 synthesis (TXB2 synthesis)
Time frame: up to 6 hours post-dose at day 8
Change in Thromboplastin Time (PT)
Time frame: up to 6 hours post-dose at day 8
Change in Activated Partial Thromboplastin Time (APTT)
Time frame: up to 6 hours post-dose at day 8
Change in Platelet Count
Time frame: up to 6 hours post-dose at day 8
Change in Leucocyte Activation
Time frame: Day 1 and 6 hours post-dose at day 8
Plasma levels of meloxicam
Time frame: pre-dose, 3 and 6 hours post-dose at day 8
Plasma levels of indomethacin
Time frame: pre-dose, 3 and 6 hours post-dose at day 8
Number of patients with adverse events
Time frame: up to 8 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 4 study testing Meloxicam - low, Meloxicam - medium and Meloxicam - high 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 5 inclusion and 23 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change from baseline in bleeding time (time frame: up to 6 hours post-dose at day 8). 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.