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

Unither Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Acute Pain

Treatments: Drug: Panadol 500 MG Oral Tablet X2; Drug: Paracetamol Uniflash 125mg; Drug: Panadol 500 MG Oral Tablet X1; Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04640376

UP-CLI-2020-001

Details and patient eligibility

About

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.

Enrollment: 407 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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407 participants in 4 patient groups, including a placebo group

Paracetamol UNIFLASH 125mg

Experimental group

Description:

1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule

Treatment:

Drug: Placebo

Drug: Paracetamol Uniflash 125mg

Placebo

Placebo Comparator group

Description:

1 Placebo sachet + 2 placebo capsule

Treatment:

Drug: Placebo

Paracetamol 500mg

Active Comparator group

Description:

1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg

Treatment:

Drug: Placebo

Drug: Panadol 500 MG Oral Tablet X1

Paracetamol 1000mg

Active Comparator group

Description:

1 Placebo sachet + 2 capsules Panadol 500mg

Treatment:

Drug: Placebo

Drug: Panadol 500 MG Oral Tablet X2