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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Placebo; Drug: Meloxicam 1.875 mg; Drug: Meloxicam 7.5 mg; Drug: Ibuprofen 400 mg; Drug: Meloxicam 3.75 mg; Drug: Ibuprofen 200 mg; Drug: Meloxicam 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183051

107.197

Details and patient eligibility

About

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.

Enrollment: 381 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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381 participants in 7 patient groups, including a placebo group

Meloxicam 15 mg

Experimental group

Treatment:

Drug: Meloxicam 15 mg

Drug: Placebo

Meloxicam 7.5 mg

Experimental group

Treatment:

Drug: Placebo

Drug: Meloxicam 7.5 mg

Meloxicam 3.75 mg

Experimental group

Treatment:

Drug: Meloxicam 3.75 mg

Drug: Placebo

Meloxicam 1.875 mg

Experimental group

Treatment:

Drug: Meloxicam 1.875 mg

Drug: Placebo

Ibuprofen 400 mg

Active Comparator group

Treatment:

Drug: Ibuprofen 400 mg

Drug: Placebo

Ibuprofen 200 mg

Active Comparator group

Treatment:

Drug: Ibuprofen 200 mg

Drug: Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo