Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction
NCT ID: NCT04640376
Last Updated: 2022-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
407 participants
INTERVENTIONAL
2021-03-24
2022-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Paracetamol UNIFLASH 125mg
1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule
Paracetamol Uniflash 125mg
Oromucosal solution 1.25 mL for buccal use
Placebo
Dummy treatment
Placebo
1 Placebo sachet + 2 placebo capsule
Placebo
Dummy treatment
Paracetamol 500mg
1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg
Panadol 500 MG Oral Tablet X1
Tablet masked in capsule
Placebo
Dummy treatment
Paracetamol 1000mg
1 Placebo sachet + 2 capsules Panadol 500mg
Panadol 500 MG Oral Tablet X2
Tablet masked in capsule
Placebo
Dummy treatment
Interventions
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Paracetamol Uniflash 125mg
Oromucosal solution 1.25 mL for buccal use
Panadol 500 MG Oral Tablet X1
Tablet masked in capsule
Panadol 500 MG Oral Tablet X2
Tablet masked in capsule
Placebo
Dummy treatment
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled to undergo the removal of one third soft-tissue impacted or not-impacted mandibular molar (associated or not to an ipsilateral erupted maxillary molar) under short-acting local anaesthetic preoperatively;
* Patients weighing \> 50 kg;
* Patients experiencing a moderate pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 40 mm and ≤ 60 mm;
* Third mandibular molar extraction completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth).
Exclusion Criteria
* Patients treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within the 3 days prior to the day of randomization (or within 5 times the elimination half-life whichever the longest);
* Patient who received other analgesic than short-acting preoperative or intraoperative local anaesthetic agents within 12 hours before the start of the surgery or peri-operatively until randomization;
* Patients with any known hypersensitivity to paracetamol, ibuprofen or ingredients contained in IMPs and Non-Investigational Medicinal Product (NIMP);
18 Years
ALL
No
Sponsors
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AIXIAL Development
UNKNOWN
Unither Pharmaceuticals, France
INDUSTRY
Responsible Party
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Locations
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CHU de Bordeaux
Bordeaux, , France
CHRU de Clermont Ferrand
Clermont-Ferrand, , France
Hôpital Louis Mourier
Colombes, , France
CHU Montpellier
Montpellier, , France
CHU de Strasbourg
Strasbourg, , France
Università degli Studi di Milano
Milan, , Italy
Department of maxilla facial Surgery -University of Udine
Udine, , Italy
University Central Stomatology GDANSK
Gdansk, , Poland
Oral Surgery Department, Central Clinical Hospital
Lodz, , Poland
Dental Practice
Lodz, , Poland
Oral surgery Medical University of Lublin
Lublin, , Poland
AW Clinic
Warsaw, , Poland
NZOZ Akademicka Poliklinika Stomatologiczna
Wroclaw, , Poland
Centro Médico Teknon - Grupo Quironsalud
Barcelona, , Spain
Hospital Odontológico Universitat Barcelona
Barcelona, , Spain
Facultad de Odontología de la Universidad de Granada
Granada, , Spain
Instituto Profesor Sada
Madrid, , Spain
Faculty of Medicine of the UNIVERSITY OF MURCIA
Murcia, , Spain
Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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Other Identifiers
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UP-CLI-2020-001
Identifier Type: -
Identifier Source: org_study_id
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