Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction
- Conditions
- Acute Pain
- Interventions
- Registration Number
- NCT04640376
- Lead Sponsor
- Unither Pharmaceuticals, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
- 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).
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracetamol UNIFLASH 125mg Paracetamol Uniflash 125mg 1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule Paracetamol 1000mg Panadol 500 MG Oral Tablet X2 1 Placebo sachet + 2 capsules Panadol 500mg Paracetamol 500mg Panadol 500 MG Oral Tablet X1 1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg Paracetamol UNIFLASH 125mg Placebo 1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule Placebo Placebo 1 Placebo sachet + 2 placebo capsule Paracetamol 1000mg Placebo 1 Placebo sachet + 2 capsules Panadol 500mg Paracetamol 500mg Placebo 1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg
- Primary Outcome Measures
Name Time Method Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min) At 60 minutes Pain Intensity Difference will be calculated using the scores of pain intensity assessed by the patient at defined time-points (T5, T10, T15, T20, T30, T45, T60 min) after the IMP intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (0= no pain and 100= worst imaginable pain) compared to baseline
Proportion of responder patients at 60 minutes (versus 500 mg of the reference oral paracetamol (Panadol®)). At 60 minutes A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline.
Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®) At 60 minutes Onset of pain relief (versus 500 mg of the reference oral paracetamol (Panadol®) At 60 minutes Defined as the period for the patient to reach a meaningful pain relief during the first 60 min post-IMP intake.
After completion of the 5-point verbal rating scale (VRS) at T5, T10, T15, T20, T30, T45, T60 min post-IMP intake assessment time points, the patient will have to answer this question "Do you consider this level of pain relief as meaningful - Yes or No?"Onset of pain relief (versus 1000 mg of the reference oral paracetamol (Panadol®)). At 60 minutes Defined as the period for the patient to reach a meaningful pain relief during the first 60 min post-IMP intake.
After completion of the a 5-point verbal rating scale at T5, T10, T15, T20, T30, T45, T60 min post-IMP intake assessment time points, the patient will have to answer this question "Do you consider this level of pain relief as meaningful - Yes or No?"
- Secondary Outcome Measures
Name Time Method 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). At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, and 6 hours. Pain Intensity Difference will be calculated using the score of pain intensity assessed by the patient at defined time-points (T5, T10, T15, T20, T30, T45, T90, T120, T180, T240, T300 and T360 min) after IMP intake or right before first intake of rescue medication using a 100-mm Visual Analogic Scale compared to baseline.
Proportion of patients taking a rescue analgesic treatment. At 6 hours Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)). At 60 minutes A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline.
Proportion of responders at 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours. At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours. A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline at each time point of the study.
Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®) At 60 minutes Total Pain Relief at 1 hour (TOTPAR0-1h), 2 hours (TOTPAR0-2h), 4 hours (TOTPAR0-4h) and 6 hours (TOTPAR0-6h) At 1 hour, 2 hours, 4 hours and 6 hours. Pain relief (PAR) will be assessed by the patient at defined time points (T5, T10, T15, T20, T30, T45, T60, T90, T120, T180, T240, T300 and T360 min) after IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale.
Period of time before taking rescue analgesic treatment intake. Up to 24 hours after dose Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®) At 360 minutes
Trial Locations
- Locations (20)
Department of maxilla facial Surgery -University of Udine
🇮🇹Udine, Italy
Dental Practice
🇵🇱Lodz, Poland
CHU de Bordeaux
🇫🇷Bordeaux, France
Hôpital Louis Mourier
🇫🇷Colombes, France
CHU Montpellier
🇫🇷Montpellier, France
CHU de Strasbourg
🇫🇷Strasbourg, France
University Central Stomatology GDANSK
🇵🇱Gdansk, Poland
Oral Surgery Department, Central Clinical Hospital
🇵🇱Lodz, Poland
Oral surgery Medical University of Lublin
🇵🇱Lublin, Poland
AW Clinic
🇵🇱Warszawa, Poland
NZOZ Akademicka Poliklinika Stomatologiczna
🇵🇱Wroclaw, Poland
Centro Médico Teknon - Grupo Quironsalud
🇪🇸Barcelona, Spain
Hospital Odontológico Universitat Barcelona
🇪🇸Barcelona, Spain
Instituto Profesor Sada
🇪🇸Madrid, Spain
Facultad de Odontología de la Universidad de Granada
🇪🇸Granada, 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
🇪🇸Sevilla, Spain
Università degli Studi di Milano
🇮🇹Milano, Italy
CHRU de Clermont Ferrand
🇫🇷Clermont Ferrand, France