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

July 4, 2014 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
381

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
60, 90, 120, 180, 240, 300 and 360 minutes after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of PID on a VAS
Time Frame: Up to 360 minutes after drug administration
Up to 360 minutes after drug administration
Sum of pain intensity differences (SPID)
Time Frame: Up to 360 minutes after drug administration
Up to 360 minutes after drug administration
Number of patients with pain decrease >=50%
Time Frame: Up to 360 minutes after drug administration
Up to 360 minutes after drug administration
Assessment of maximum pain decrease on a VAS
Time Frame: Up to 360 minutes after drug administration
Up to 360 minutes after drug administration
Number of withdrawals due to safety reasons
Time Frame: Up to 7 days after drug administration
Up to 7 days after drug administration
Number, nature and severity of adverse events
Time Frame: Up to 7 days after drug administration
Up to 7 days after drug administration
Total pain relief (TOTPAR) assessed by patient (Area under the pain relief-by time curve)
Time Frame: Up to 360 minutes after drug administration
Up to 360 minutes after drug administration
Assessment of onset of analgesic action
Time Frame: Up to 2 hours after surgery
Up to 2 hours after surgery
Final assessment of efficacy by patient on a 4-point verbal rating scale (VRS)
Time Frame: 6 hours after drug administration
6 hours after drug administration
Final assessment of efficacy by investigator on a 4-point VRS
Time Frame: 2 hours after drug administration
2 hours after drug administration
Change from baseline in laboratory values
Time Frame: Baseline, up to 7 days after drug administration
Baseline, up to 7 days after drug administration
Assessment of the progress of healing of the extraction site
Time Frame: 3-7 days after drug administration
3-7 days after drug administration
Patient's assessment of overall tolerability on a 4-point rating scale
Time Frame: Day 7 after drug administration
Day 7 after drug administration
Investigator's assessment of overall tolerability on a 4-point rating scale
Time Frame: Day 7 after drug administration
Day 7 after drug administration
Pain relief assessed by patient on a 5-point VRS
Time Frame: Up to 360 minutesafter drug administration
Up to 360 minutesafter drug administration
Number of withdrawals due to inadequate efficacy
Time Frame: Up to 7 days after drug administration
Up to 7 days after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 1998

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 107.197

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