Clinical trial

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.

Name

UP-CLI-2020-001

Description

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.

Trial arms

Trial start

2021-03-24

Estimated PCD

2022-11-08

Trial end

2022-11-10

Status

Completed

Phase

Early phase I

Treatment

Paracetamol Uniflash 125mg

Oromucosal solution 1.25 mL for buccal use

Arms:

Paracetamol UNIFLASH 125mg

Panadol 500 MG Oral Tablet X1

Tablet masked in capsule

Arms:

Paracetamol 500mg

Panadol 500 MG Oral Tablet X2

Tablet masked in capsule

Arms:

Paracetamol 1000mg

Placebo

Dummy treatment

Arms:

Paracetamol 1000mg, Paracetamol 500mg, Paracetamol UNIFLASH 125mg, Placebo

Size

407

Primary endpoint

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

At 60 minutes

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

At 60 minutes

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

At 60 minutes

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

At 60 minutes

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

At 60 minutes

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);

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "Double-blind. Participants, Investigators, and all persons involved in the conduct, data management, and analysis of the study will be fully blind to the participant's treatment.", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 407, 'type': 'ACTUAL'}}

Updated at

2022-11-14

1 organization

3 products

1 indication

Product

Panadol

Indication

Pain

Organization

Unither Pharmaceuticals

Product

Placebo

Product

Paracetamol