MedTrace Logo

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

NCT04640376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2022-11-14

No results posted yet for this study

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.

Conditions

  • Acute Pain

Interventions

DRUG

Paracetamol Uniflash 125mg

Oromucosal solution 1.25 mL for buccal use

DRUG

Panadol 500 MG Oral Tablet X1

Tablet masked in capsule

DRUG

Panadol 500 MG Oral Tablet X2

Tablet masked in capsule

DRUG

Placebo

Dummy treatment

Sponsors & Collaborators

  • AIXIAL Development

    collaborator UNKNOWN

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2022-11-08
Completion
2022-11-10

Countries

  • France
  • Italy
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640376 on ClinicalTrials.gov