Adult patients with moderate to severe dental pain MedDRA version: 14.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Code: E-58425
Pharmaceutical Form: Tablet
INN or Proposed INN: Tramadol Celecoxib
CAS Number: 1221565-82-7
Current Sponsor code: E-58425
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Laboratorios del Dr. Esteve, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Moderate or severe pain (score of at least 50mm on VAS) as a result of an oral surgical procedure under local anesthesia and/or sedation. The procedure must have involved extraction of at least two impacted third molars requiring bone removal. If only two impacted third molars are extracted, they must be ipsilateral and require bone removal. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: -Received any analgesic medication other than short-acting preoperative or intraoperative anesthetic agents within 12 hours before taking trial medication. -Patients who received any analgesic medication other than the study drug immediately after the oral surgical procedure was completed will also be excluded. -Patients with any complication during surgery. -Received a long-acting nonsteroidal anti-inflammatory drug (NSAID) within three days prior to dosing. -History of seizures or drug or alcohol abuse within six months. -Received monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within four weeks of study entry. -Evidence of renal or hepatic dysfunction, or peptic ulcer disease. -Received selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine, fluoxetine), diet pills (including fenfluramine, phentermine, etc.), or methylphenidate (Ritalin®) within four weeks of study entry. -Sensitive or allergic to tramadol, celecoxib or other NSAIDs, or aspirin. -At risk in terms of precautions, warnings, and contraindications in the package insert for Adolonta® tramadol hydrochloride, Celebrex® celecoxib. -Coagulation disorders. -Non controlled high blood pressure, diabetes or cardiac failure. -Asthma or history of bronchospasm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the effective dose between 4 strenghts of E-58425 for moderate to severe dental pain;Secondary Objective: To asses the efficacy and safety of E-58425;Primary end point(s): Analgesic efficacy measurements that will include pain intensity, pain relief, use of rescue medication, time to perceptible and meaningful pain relief and overall assessment of the study medication.;Timepoint(s) of evaluation of this end point: Pain intensity will be assessed by the Visual Analogue Scale. Baseline pain and pain at 10 min, 20min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2 h, 2h 15min, 2h 30min, 2h 45min, 3h, 3h 15min, 3h 30min, 3h 45min, 4h, 4h 30 min, 5h, 5h 30 min, 6h, 7h, 8h, 10h, 12h and 24h after receiving the study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Plasma concentrations of E-58425 Safety and tolerability: Adverse (AEs), Safety laboratory tests, Dental evaluation, General medical examination, Vital signs (pulse rate and blood pressure in sitting position, body temperature), 12-lead ECG (PR-, QRS-, QT and QTc-intervals);Timepoint(s) of evaluation of this end point: Blood samples will be taken from patients of at least one study centre at 0, 2 and 6 hours after administration of the study medication or at the time the patient decides to withdraw from the study (if the patient consents) for determination of plasma levels of E-58425 (Tramadol, M1 and celecoxib). Safety and tolerability: up to one week | — |
Countries
Spain
Contacts
Public ContactDepartamento Investigación Clínica
Laboratorios del Dr. Esteve, S.A
Outcome results
None listed