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 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Meloxicam 15 mg; Drug: Meloxicam 7.5 mg; Drug: Meloxicam 3.75 mg; Drug: Meloxicam 1.875 mg; Drug: Ibuprofen 400 mg; Drug: Ibuprofen 200 mg

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Meloxicam 15 mg	Drug: Placebo; Drug: Meloxicam 15 mg
Experimental: Meloxicam 7.5 mg	Drug: Placebo; Drug: Meloxicam 7.5 mg
Experimental: Meloxicam 3.75 mg	Drug: Placebo; Drug: Meloxicam 3.75 mg
Experimental: Meloxicam 1.875 mg	Drug: Placebo; Drug: Meloxicam 1.875 mg
Active Comparator: Ibuprofen 400 mg	Drug: Placebo; Drug: Ibuprofen 400 mg
Active Comparator: Ibuprofen 200 mg	Drug: Placebo; Drug: Ibuprofen 200 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of pain intensity differences (PID) on a visual analogue scale (VAS, 100 mm) from one hour onwards	60, 90, 120, 180, 240, 300 and 360 minutes after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of PID on a VAS	Up to 360 minutes after drug administration
Sum of pain intensity differences (SPID)	Up to 360 minutes after drug administration
Number of patients with pain decrease >=50%	Up to 360 minutes after drug administration
Assessment of maximum pain decrease on a VAS	Up to 360 minutes after drug administration
Number of withdrawals due to safety reasons	Up to 7 days after drug administration
Number, nature and severity of adverse events	Up to 7 days after drug administration
Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)	Up to 360 minutes after drug administration
Assessment of onset of analgesic action	Up to 2 hours after surgery
Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)	6 hours after drug administration
Final assessment of efficacy by investigator on a 4-point VRS	2 hours after drug administration
Change from baseline in laboratory values	Baseline, up to 7 days after drug administration
Assessment of the progress of healing of the extraction site	3-7 days after drug administration
Patient's assessment of overall tolerability on a 4-point rating scale	Day 7 after drug administration
Investigator's assessment of overall tolerability on a 4-point rating scale	Day 7 after drug administration
Pain relief assessed by patient on a 5-point VRS	Up to 360 minutesafter drug administration
Number of withdrawals due to inadequate efficacy	Up to 7 days after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): October 1, 1998

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Ibuprofen; Meloxicam
• Other Study ID Numbers: 107.197