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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183051
• Other study ID #: 107.197
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2014
• Last updated: July 4, 2014
• Start date: April 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencySpain: Agencia Española de Medicamentos y Productos SanitariosUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. primary completion date: October 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Meloxicam 7.5 mg

• Meloxicam 3.75 mg

• Meloxicam 1.875 mg

• Ibuprofen 200 mg

• Placebo

• Meloxicam 15 mg

• Ibuprofen 400 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of PID on a VAS		Up to 360 minutes after drug administration	No
Secondary	Sum of pain intensity differences (SPID)		Up to 360 minutes after drug administration	No
Secondary	Number of patients with pain decrease >=50%		Up to 360 minutes after drug administration	No
Secondary	Assessment of maximum pain decrease on a VAS		Up to 360 minutes after drug administration	No
Secondary	Number of withdrawals due to safety reasons		Up to 7 days after drug administration	No
Secondary	Number, nature and severity of adverse events		Up to 7 days after drug administration	No
Secondary	Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)		Up to 360 minutes after drug administration	No
Secondary	Assessment of onset of analgesic action		Up to 2 hours after surgery	No
Secondary	Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)		6 hours after drug administration	No
Secondary	Final assessment of efficacy by investigator on a 4-point VRS		2 hours after drug administration	No
Secondary	Change from baseline in laboratory values		Baseline, up to 7 days after drug administration	No
Secondary	Assessment of the progress of healing of the extraction site		3-7 days after drug administration	No
Secondary	Patient's assessment of overall tolerability on a 4-point rating scale		Day 7 after drug administration	No
Secondary	Investigator's assessment of overall tolerability on a 4-point rating scale		Day 7 after drug administration	No
Secondary	Pain relief assessed by patient on a 5-point VRS		Up to 360 minutesafter drug administration	No
Secondary	Number of withdrawals due to inadequate efficacy		Up to 7 days after drug administration	No

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