Clinical trial NCT04640376: Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction
Official title: Comparison of the Analgesic Effect of a New Paracetamol Formulation (Paracetamol UNIFLASH) for Buccal Use and Two Different Doses of an Oral Paracetamol Form Controlled Versus Placebo in Patients Suffering From Moderate Pain Due to a Tooth Extraction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Keywords: paracetamol
Lead sponsor: Unither Pharmaceuticals, France
Sponsor class: INDUSTRY
Collaborators: name: AIXIAL Development
First posted: 2020-11-23
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the analgesic efficacy of single dose of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use in comparison to two different doses of an oral paracetamol form controlled versus placebo.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged from 18 years of age
* 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;

Additional inclusion criteria

* 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:

* Patient who undergoes an extraction of contralateral molar in the same procedure or a bony-impacted molar;
* 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);

Primary outcomes:
measure: Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min)
timeFrame: At 60 minutes
measure: Onset of pain relief (versus 500 mg of the reference oral paracetamol (Panadol®)
timeFrame: At 60 minutes
measure: Proportion of responder patients at 60 minutes (versus 500 mg of the reference oral paracetamol (Panadol®)).
timeFrame: At 60 minutes
measure: Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®)
timeFrame: At 60 minutes
measure: Onset of pain relief (versus 1000 mg of the reference oral paracetamol (Panadol®)).
timeFrame: At 60 minutes
Secondary outcomes:
measure: Sum of Pain Intensity Difference at 5 minutes (SPID0-5min), 10 minutes (SPID0-10min), 30 minutes (SPID0-30min), 45 minutes (SPID0-45min), 1 hour (SPID0-1h), 2 hours (SPID0-2h), 4 hours (SPID0-4h), and 6 hours (SPID0-6h).
timeFrame: At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, and 6 hours.
measure: Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)).
timeFrame: At 60 minutes
measure: Proportion of responders at 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.
timeFrame: At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.
measure: Total Pain Relief at 1 hour (TOTPAR0-1h), 2 hours (TOTPAR0-2h), 4 hours (TOTPAR0-4h) and 6 hours (TOTPAR0-6h)
timeFrame: At 1 hour, 2 hours, 4 hours and 6 hours.
measure: Period of time before taking rescue analgesic treatment intake.
timeFrame: Up to 24 hours after dose
measure: Proportion of patients taking a rescue analgesic treatment.
timeFrame: At 6 hours
measure: Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)
timeFrame: At 60 minutes
measure: Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)
timeFrame: At 360 minutes
Other outcomes:
measure: Occurrence and severity of serious and non-serious Adverse Events (AEs).
timeFrame: Up to 24 hours after dose
measure: The test volume formulation acceptability
timeFrame: At 6 hours
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont Ferrand
country: France
facility: CHRU de Clermont Ferrand
city: Colombes
country: France
facility: Hôpital Louis Mourier
city: Montpellier
country: France
facility: CHU Montpellier
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Milano
country: Italy
facility: Università degli Studi di Milano
city: Udine
country: Italy
facility: Department of maxilla facial Surgery -University of Udine
city: Gdansk
country: Poland
facility: University Central Stomatology GDANSK
city: Lodz
country: Poland
facility: Oral Surgery Department, Central Clinical Hospital
city: Lodz
country: Poland
facility: Dental Practice
city: Lublin
country: Poland
facility: Oral surgery Medical University of Lublin
city: Warszawa
country: Poland
facility: AW Clinic
city: Wroclaw
country: Poland
facility: NZOZ Akademicka Poliklinika Stomatologiczna
city: Barcelona
country: Spain
facility: Centro Médico Teknon - Grupo Quironsalud
city: Barcelona
country: Spain
facility: Hospital Odontológico Universitat Barcelona
city: Granada
country: Spain
facility: Facultad de Odontología de la Universidad de Granada
city: Madrid
country: Spain
facility: Instituto Profesor Sada
city: Murcia
country: Spain
facility: Faculty of Medicine of the UNIVERSITY OF MURCIA
city: Santiago de Compostela
country: Spain
facility: Hospitalario Universitario de Santiago (CHUS)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
References: