PainPhase 2NCT02183051
Study to Compare the the Analgesic Efficacy and Tolerability of Meloxicam Versus Placebo and Ibuprofen in the Treatment of Pain After Surgery of the Third Molar
A Phase 2 study testing Meloxicam 7.5 mg, Meloxicam 3.75 mg and Meloxicam 1.875 mg in people with Pain, run by Boehringer Ingelheim.
Trial summary
To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg administered in a single dose, over an observation period of 6 hours in the treatment of pain after surgery of the third molar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Meloxicam 7.5 mg, Meloxicam 3.75 mg and Meloxicam 1.875 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- No sites listed yet
- Study dates
- Apr 1998to Oct 1998
- 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
- Male or female aged 18 years or above
- Patients undergoing removal of one impacted mandibular third molar under local anesthesia. (Short duration anaesthetics will be allowed, i.e. mepivacaine 3% in Italy and Spain and xylocaine in USA, both without vasoconstrictors) Only patients with type of inclusion II to IV have to be included (type II, molar in the submucosa; type III, molar partially included in the bone; type IV, molar fully included in the bone)
- Assessment of pain must be at least 50 mm on a 100 mm visual analogue scale (VAS)
- Patient informed consent in accordance with local legislation.
Who cannot join
- Type I of inclusion (molar partially or totally erupted)
- Known or suspected hypersensitivity to trial drug or their excipients, analgesics, antipyretics or nonsteroidal antiinflammatory drug (NSAIDs)
- Any clinical evidence of active peptic ulceration during the last six month
- Recurrent ulcers
- Pregnancy or breast feeding
- Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
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- Concomitant treatment with anti-coagulants (including heparin), lithium
- Concomitant administration of other anti inflammatory or analgesic agents
- Administration of any drug with analgesic properties in the 24 h previous to the administration of the study drug, except the local anesthetic for the surgery
- Administration of any antibiotics
- Significant perioperative complication judged by the oral surgeon
- Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, hematological disease (including bleeding disorders), mental disturbance, ulcerative colitis
- Any other disease that could interfere with the evaluation of efficacy and safety
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial
- Patient unable to comply with the protocol
About this study
Official title: A Short Term Double-blind Trial to Compare the the Analgesic Efficacy and Tolerability of Meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg Oral (Quick Tablet) Versus Placebo and Ibuprofen 400 mg and 200 mg Oral in the Treatment of Pain After Surgery of the Third Molar
To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg administered in a single dose, over an observation period of 6 hours in the treatment of pain after surgery of the third molar.
- Conditions
- Pain
- Being tested
- Meloxicam 7.5 mg, Meloxicam 3.75 mg, Meloxicam 1.875 mg, Ibuprofen 200 mg, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam 7.5 mgDrug
Meloxicam 3.75 mgDrug
Meloxicam 1.875 mgDrug
Ibuprofen 200 mgDrug
PlaceboDrug
Meloxicam 15 mgDrug
Ibuprofen 400 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam 15 mg | Experimental | Not described Receives: Drug: Placebo; Drug: Meloxicam 15 mg |
| Meloxicam 7.5 mg | Experimental | Not described Receives: Drug: Meloxicam 7.5 mg; Drug: Placebo |
| Meloxicam 3.75 mg | Experimental | Not described Receives: Drug: Meloxicam 3.75 mg; Drug: Placebo |
| Meloxicam 1.875 mg | Experimental | Not described Receives: Drug: Meloxicam 1.875 mg; Drug: Placebo |
| Ibuprofen 400 mg | Active comparator | Not described Receives: Drug: Placebo; Drug: Ibuprofen 400 mg |
| Ibuprofen 200 mg | Active comparator | Not described Receives: Drug: Ibuprofen 200 mg; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards
Measured: 60, 90, 120, 180, 240, 300 and 360 minutes after drug administration
Secondary outcomes (16)
Assessment of PID on a VAS
Measured: Up to 360 minutes after drug administration
Sum of pain intensity differences (SPID)
Measured: Up to 360 minutes after drug administration
Number of patients with pain decrease >=50%
Measured: Up to 360 minutes after drug administration
Assessment of maximum pain decrease on a VAS
Measured: Up to 360 minutes after drug administration
Number of withdrawals due to safety reasons
Measured: Up to 7 days after drug administration
Number, nature and severity of adverse events
Measured: Up to 7 days after drug administration
Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)
Measured: Up to 360 minutes after drug administration
Assessment of onset of analgesic action
Measured: Up to 2 hours after surgery
Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)
Measured: 6 hours after drug administration
Final assessment of efficacy by investigator on a 4-point VRS
Measured: 2 hours after drug administration
Change from baseline in laboratory values
Measured: Baseline, up to 7 days after drug administration
Assessment of the progress of healing of the extraction site
Measured: 3-7 days after drug administration
Patient's assessment of overall tolerability on a 4-point rating scale
Measured: Day 7 after drug administration
Investigator's assessment of overall tolerability on a 4-point rating scale
Measured: Day 7 after drug administration
Pain relief assessed by patient on a 5-point VRS
Measured: Up to 360 minutesafter drug administration
Number of withdrawals due to inadequate efficacy
Measured: Up to 7 days after drug administration
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 startApr 1998
- Primary completionOct 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 381 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
- NCT02183051
- Sponsor's protocol ID
- 107.197
- 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 Short Term Double-blind Trial to Compare the the Analgesic Efficacy and Tolerability of Meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg Oral (Quick Tablet) Versus Placebo and Ibuprofen 400 mg and 200 mg Oral in the Treatment of Pain After Surgery of the Third Molar
- ClinicalTrials.gov ID
- NCT02183051
- Acronym / sponsor ID
- 107.197
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Oct 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.
To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg administered in a single dose, over an observation period of 6 hours in the treatment of pain after surgery of the third molar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Meloxicam 15 mg | Experimental | Drug: Placebo, Drug: Meloxicam 15 mg |
| Meloxicam 7.5 mg | Experimental | Drug: Meloxicam 7.5 mg, Drug: Placebo |
| Meloxicam 3.75 mg | Experimental | Drug: Meloxicam 3.75 mg, Drug: Placebo |
| Meloxicam 1.875 mg | Experimental | Drug: Meloxicam 1.875 mg, Drug: Placebo |
| Ibuprofen 400 mg | Active comparator | Drug: Placebo, Drug: Ibuprofen 400 mg |
| Ibuprofen 200 mg | Active comparator | Drug: Ibuprofen 200 mg, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 years or above
- Patients undergoing removal of one impacted mandibular third molar under local anesthesia. (Short duration anaesthetics will be allowed, i.e. mepivacaine 3% in Italy and Spain and xylocaine in USA, both without vasoconstrictors) Only patients with type of inclusion II to IV have to be included (type II, molar in the submucosa; type III, molar partially included in the bone; type IV, molar fully included in the bone)
- Assessment of pain must be at least 50 mm on a 100 mm visual analogue scale (VAS)
- Patient informed consent in accordance with local legislation.
Key exclusion criteria (16 listed)
- Type I of inclusion (molar partially or totally erupted)
- Known or suspected hypersensitivity to trial drug or their excipients, analgesics, antipyretics or nonsteroidal antiinflammatory drug (NSAIDs)
- Any clinical evidence of active peptic ulceration during the last six month
- Recurrent ulcers
- Pregnancy or breast feeding
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 7.5 mg | Drug | Meloxicam 7.5 mg |
| Meloxicam 3.75 mg | Drug | Meloxicam 3.75 mg |
| Meloxicam 1.875 mg | Drug | Meloxicam 1.875 mg |
| Ibuprofen 200 mg | Drug | Ibuprofen 200 mg |
| Placebo | Drug | Ibuprofen 200 mg, Ibuprofen 400 mg, Meloxicam 1.875 mg, Meloxicam 15 mg, Meloxicam 3.75 mg, Meloxicam 7.5 mg, Placebo |
| Meloxicam 15 mg | Drug | Meloxicam 15 mg |
| Ibuprofen 400 mg | Drug | Ibuprofen 400 mg |
Primary outcome
Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards
Time frame: 60, 90, 120, 180, 240, 300 and 360 minutes after drug administration
16 secondary outcomes
Assessment of PID on a VAS
Time frame: Up to 360 minutes after drug administration
Sum of pain intensity differences (SPID)
Time frame: Up to 360 minutes after drug administration
Number of patients with pain decrease >=50%
Time frame: Up to 360 minutes after drug administration
Assessment of maximum pain decrease on a VAS
Time frame: Up to 360 minutes after drug administration
Number of withdrawals due to safety reasons
Time frame: Up to 7 days after drug administration
Number, nature and severity of adverse events
Time frame: Up to 7 days after drug administration
Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)
Time frame: Up to 360 minutes after drug administration
Assessment of onset of analgesic action
Time frame: Up to 2 hours after surgery
Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)
Time frame: 6 hours after drug administration
Final assessment of efficacy by investigator on a 4-point VRS
Time frame: 2 hours after drug administration
Change from baseline in laboratory values
Time frame: Baseline, up to 7 days after drug administration
Assessment of the progress of healing of the extraction site
Time frame: 3-7 days after drug administration
Patient's assessment of overall tolerability on a 4-point rating scale
Time frame: Day 7 after drug administration
Investigator's assessment of overall tolerability on a 4-point rating scale
Time frame: Day 7 after drug administration
Pain relief assessed by patient on a 5-point VRS
Time frame: Up to 360 minutesafter drug administration
Number of withdrawals due to inadequate efficacy
Time frame: Up to 7 days after drug administration
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.
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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 2 study testing Meloxicam 7.5 mg, Meloxicam 3.75 mg and Meloxicam 1.875 mg in people with Pain, 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 16 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 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?
Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards (time frame: 60, 90, 120, 180, 240, 300 and 360 minutes after drug administration). 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.