Clinical trial NCT02183051: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards
timeFrame: 60, 90, 120, 180, 240, 300 and 360 minutes after drug administration
Secondary outcomes:
measure: Assessment of PID on a VAS
timeFrame: Up to 360 minutes after drug administration
measure: Sum of pain intensity differences (SPID)
timeFrame: Up to 360 minutes after drug administration
measure: Number of patients with pain decrease >=50%
timeFrame: Up to 360 minutes after drug administration
measure: Assessment of maximum pain decrease on a VAS
timeFrame: Up to 360 minutes after drug administration
measure: Number of withdrawals due to safety reasons
timeFrame: Up to 7 days after drug administration
measure: Number, nature and severity of adverse events
timeFrame: Up to 7 days after drug administration
measure: Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)
timeFrame: Up to 360 minutes after drug administration
measure: Assessment of onset of analgesic action
timeFrame: Up to 2 hours after surgery
measure: Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)
timeFrame: 6 hours after drug administration
measure: Final assessment of efficacy by investigator on a 4-point VRS
timeFrame: 2 hours after drug administration
measure: Change from baseline in laboratory values
timeFrame: Baseline, up to 7 days after drug administration
measure: Assessment of the progress of healing of the extraction site
timeFrame: 3-7 days after drug administration
measure: Patient's assessment of overall tolerability on a 4-point rating scale
timeFrame: Day 7 after drug administration
measure: Investigator's assessment of overall tolerability on a 4-point rating scale
timeFrame: Day 7 after drug administration
measure: Pain relief assessed by patient on a 5-point VRS
timeFrame: Up to 360 minutesafter drug administration
measure: Number of withdrawals due to inadequate efficacy
timeFrame: Up to 7 days after drug administration
Other outcomes:
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