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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

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ClinicalTrials.gov Identifier: NCT02183051
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Meloxicam 7.5 mg Drug: Meloxicam 3.75 mg Drug: Meloxicam 1.875 mg Drug: Ibuprofen 200 mg Drug: Placebo Drug: Meloxicam 15 mg Drug: Ibuprofen 400 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 1998
Actual Primary Completion Date : October 1998

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meloxicam 15 mg Drug: Placebo
Drug: Meloxicam 15 mg
Experimental: Meloxicam 7.5 mg Drug: Meloxicam 7.5 mg
Drug: Placebo
Experimental: Meloxicam 3.75 mg Drug: Meloxicam 3.75 mg
Drug: Placebo
Experimental: Meloxicam 1.875 mg Drug: Meloxicam 1.875 mg
Drug: Placebo
Active Comparator: Ibuprofen 400 mg Drug: Placebo
Drug: Ibuprofen 400 mg
Active Comparator: Ibuprofen 200 mg Drug: Ibuprofen 200 mg
Drug: Placebo
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. 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 ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183051    
Other Study ID Numbers: 107.197
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Ibuprofen
Meloxicam
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors