A clinical trial to find the best dose of a new pain-killer (E-58425) after dental surgery

Phase 1

• Conditions: Adult patients with moderate to severe dental pain; MedDRA version: 14.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2011-002778-21-ES
• Lead Sponsor: aboratorios del Dr. Esteve, S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-28
• Study Completion: 2013-02-13
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 334

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

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified