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Completed

NCT Number: NCT04640376

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Paracetamol Uniflash 125mg

Drug

Oromucosal solution 1.25 mL for buccal use

Panadol 500 MG Oral Tablet X1

Drug

Tablet masked in capsule

Panadol 500 MG Oral Tablet X2

Drug

Tablet masked in capsule

Placebo

Drug

Dummy treatment

Primary outcomes

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

    Time frame: At 60 minutes

    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

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

    Time frame: At 60 minutes

    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?"

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

    Time frame: At 60 minutes

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

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

    Time frame: At 60 minutes

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

    Time frame: At 60 minutes

    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 outcomes

  1. 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).

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

    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.

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

    Time frame: At 60 minutes

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

  3. Proportion of responders at 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.

    Time frame: 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.

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

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

    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.

  5. Period of time before taking rescue analgesic treatment intake.

    Time frame: Up to 24 hours after dose

  6. Proportion of patients taking a rescue analgesic treatment.

    Time frame: At 6 hours

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

    Time frame: At 60 minutes

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

    Time frame: At 360 minutes

Other outcomes

  1. Occurrence and severity of serious and non-serious Adverse Events (AEs).

    Time frame: Up to 24 hours after dose

  2. The test volume formulation acceptability

    Time frame: At 6 hours

    Patients will answer a question enquiring about the satisfaction with the new oromucosal solution in terms of solution volume

Sponsors and collaborators

Lead sponsor

Unither Pharmaceuticals, France

Industry

Collaborators

  • AIXIAL Development

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2020
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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