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Completed

NCT Number: 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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
1998
Primary completion
1998
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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