NCT02183051

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for phase_2 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1998

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1998

Completed
15.8 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

July 4, 2014

Last Update Submit

July 4, 2014

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (7)

Meloxicam 15 mg

EXPERIMENTAL
Drug: PlaceboDrug: Meloxicam 15 mg

Meloxicam 7.5 mg

EXPERIMENTAL
Drug: Meloxicam 7.5 mgDrug: Placebo

Meloxicam 3.75 mg

EXPERIMENTAL
Drug: Meloxicam 3.75 mgDrug: Placebo

Meloxicam 1.875 mg

EXPERIMENTAL
Drug: Meloxicam 1.875 mgDrug: Placebo

Ibuprofen 400 mg

ACTIVE COMPARATOR
Drug: PlaceboDrug: Ibuprofen 400 mg

Ibuprofen 200 mg

ACTIVE COMPARATOR
Drug: Ibuprofen 200 mgDrug: Placebo

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Meloxicam 7.5 mgDRUG
Meloxicam 7.5 mg
Meloxicam 3.75 mgDRUG
Meloxicam 3.75 mg
Meloxicam 1.875 mgDRUG
Meloxicam 1.875 mg
Ibuprofen 200 mgDRUG
Ibuprofen 200 mg
PlaceboDRUG
Ibuprofen 200 mgIbuprofen 400 mgMeloxicam 1.875 mgMeloxicam 15 mgMeloxicam 3.75 mgMeloxicam 7.5 mgPlacebo
Meloxicam 15 mgDRUG
Meloxicam 15 mg
Ibuprofen 400 mgDRUG
Ibuprofen 400 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 years or above
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

MeloxicamIbuprofen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 8, 2014

Study Start

April 1, 1998

Primary Completion

October 1, 1998

Last Updated

July 8, 2014

Record last verified: 2014-07