Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction

Unither Pharmaceuticals, France407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

407

Conditions

Acute Pain

Interventions

Paracetamol Uniflash 125mgDRUG

Oromucosal solution 1.25 mL for buccal use

Panadol 500 MG Oral Tablet X1DRUG

Tablet masked in capsule

Panadol 500 MG Oral Tablet X2DRUG

Tablet masked in capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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);

Locations (20)

CHU de Bordeaux

Bordeaux, France

CHRU de Clermont Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min)

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

Time frame: At 60 minutes

Onset of pain relief (versus 500 mg of the reference oral paracetamol (Panadol®)

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?"

Time frame: At 60 minutes

Proportion of responder patients at 60 minutes (versus 500 mg of the reference oral paracetamol (Panadol®)).

A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline.

Time frame: At 60 minutes

Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®)

Time frame: At 60 minutes

Onset of pain relief (versus 1000 mg of the reference oral paracetamol (Panadol®)).

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?"

Time frame: At 60 minutes

Secondary Outcomes

Data from ClinicalTrials.gov

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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).

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.

Time frame: At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, and 6 hours.

Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)).

A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline.

Time frame: At 60 minutes

Proportion of responders 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.

Time frame: At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.

Total Pain Relief at 1 hour (TOTPAR0-1h), 2 hours (TOTPAR0-2h), 4 hours (TOTPAR0-4h) and 6 hours (TOTPAR0-6h)

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.

Time frame: At 1 hour, 2 hours, 4 hours and 6 hours.

Period of time before taking rescue analgesic treatment intake.

Time frame: Up to 24 hours after dose

Proportion of patients taking a rescue analgesic treatment.

Time frame: At 6 hours

Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)

Time frame: At 60 minutes

Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)

Time frame: At 360 minutes