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

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paracetamol Uniflash 125mg
Panadol 500 MG Oral Tablet X1
Panadol 500 MG Oral Tablet X2
Placebo
Sponsored by
Unither Pharmaceuticals, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring paracetamol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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);

Sites / Locations

  • CHU de Bordeaux
  • CHRU de Clermont Ferrand
  • Hôpital Louis Mourier
  • CHU Montpellier
  • CHU de Strasbourg
  • Università degli Studi di Milano
  • Department of maxilla facial Surgery -University of Udine
  • University Central Stomatology GDANSK
  • Oral Surgery Department, Central Clinical Hospital
  • Dental Practice
  • Oral surgery Medical University of Lublin
  • AW Clinic
  • NZOZ Akademicka Poliklinika Stomatologiczna
  • Centro Médico Teknon - Grupo Quironsalud
  • Hospital Odontológico Universitat Barcelona
  • Facultad de Odontología de la Universidad de Granada
  • Instituto Profesor Sada
  • Faculty of Medicine of the UNIVERSITY OF MURCIA
  • Hospitalario Universitario de Santiago (CHUS)
  • Hospital Universitario Virgen del Rocio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Paracetamol UNIFLASH 125mg

Placebo

Paracetamol 500mg

Paracetamol 1000mg

Arm Description

1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule

1 Placebo sachet + 2 placebo capsule

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

1 Placebo sachet + 2 capsules Panadol 500mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
Period of time before taking rescue analgesic treatment intake.
Proportion of patients taking a rescue analgesic treatment.
Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)
Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)

Full Information

First Posted
November 16, 2020
Last Updated
November 10, 2022
Sponsor
Unither Pharmaceuticals, France
Collaborators
AIXIAL Development
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1. Study Identification

Unique Protocol Identification Number
NCT04640376
Brief Title
Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
November 8, 2022 (Actual)
Study Completion Date
November 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unither Pharmaceuticals, France
Collaborators
AIXIAL Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
paracetamol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol UNIFLASH 125mg
Arm Type
Experimental
Arm Description
1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 Placebo sachet + 2 placebo capsule
Arm Title
Paracetamol 500mg
Arm Type
Active Comparator
Arm Description
1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg
Arm Title
Paracetamol 1000mg
Arm Type
Active Comparator
Arm Description
1 Placebo sachet + 2 capsules Panadol 500mg
Intervention Type
Drug
Intervention Name(s)
Paracetamol Uniflash 125mg
Intervention Description
Oromucosal solution 1.25 mL for buccal use
Intervention Type
Drug
Intervention Name(s)
Panadol 500 MG Oral Tablet X1
Intervention Description
Tablet masked in capsule
Intervention Type
Drug
Intervention Name(s)
Panadol 500 MG Oral Tablet X2
Intervention Description
Tablet masked in capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dummy treatment
Primary Outcome Measure Information:
Title
Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min)
Description
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
Title
Onset of pain relief (versus 500 mg of the reference oral paracetamol (Panadol®)
Description
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
Title
Proportion of responder patients at 60 minutes (versus 500 mg of the reference oral paracetamol (Panadol®)).
Description
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
Title
Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®)
Time Frame
At 60 minutes
Title
Onset of pain relief (versus 1000 mg of the reference oral paracetamol (Panadol®)).
Description
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 Outcome Measure Information:
Title
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).
Description
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.
Title
Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)).
Description
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
Title
Proportion of responders at 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.
Description
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.
Title
Total Pain Relief at 1 hour (TOTPAR0-1h), 2 hours (TOTPAR0-2h), 4 hours (TOTPAR0-4h) and 6 hours (TOTPAR0-6h)
Description
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.
Title
Period of time before taking rescue analgesic treatment intake.
Time Frame
Up to 24 hours after dose
Title
Proportion of patients taking a rescue analgesic treatment.
Time Frame
At 6 hours
Title
Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)
Time Frame
At 60 minutes
Title
Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)
Time Frame
At 360 minutes
Other Pre-specified Outcome Measures:
Title
Occurrence and severity of serious and non-serious Adverse Events (AEs).
Time Frame
Up to 24 hours after dose
Title
The test volume formulation acceptability
Description
Patients will answer a question enquiring about the satisfaction with the new oromucosal solution in terms of solution volume
Time Frame
At 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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);
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
CHRU de Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
Country
France
Facility Name
Università degli Studi di Milano
City
Milano
Country
Italy
Facility Name
Department of maxilla facial Surgery -University of Udine
City
Udine
Country
Italy
Facility Name
University Central Stomatology GDANSK
City
Gdansk
Country
Poland
Facility Name
Oral Surgery Department, Central Clinical Hospital
City
Lodz
ZIP/Postal Code
92213
Country
Poland
Facility Name
Dental Practice
City
Lodz
Country
Poland
Facility Name
Oral surgery Medical University of Lublin
City
Lublin
Country
Poland
Facility Name
AW Clinic
City
Warszawa
Country
Poland
Facility Name
NZOZ Akademicka Poliklinika Stomatologiczna
City
Wroclaw
ZIP/Postal Code
50425
Country
Poland
Facility Name
Centro Médico Teknon - Grupo Quironsalud
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Odontológico Universitat Barcelona
City
Barcelona
Country
Spain
Facility Name
Facultad de Odontología de la Universidad de Granada
City
Granada
Country
Spain
Facility Name
Instituto Profesor Sada
City
Madrid
Country
Spain
Facility Name
Faculty of Medicine of the UNIVERSITY OF MURCIA
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Facility Name
Hospitalario Universitario de Santiago (CHUS)
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this stage, IPD sharing plan has to been discussed and finalised

Learn more about this trial

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

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