Acute Pain
Conditions
Keywords
paracetamol
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.
Interventions
DRUGParacetamol Uniflash 125mg
Oromucosal solution 1.25 mL for buccal use
DRUGPanadol 500 MG Oral Tablet X1
Tablet masked in capsule
DRUGPanadol 500 MG Oral Tablet X2
Tablet masked in capsule
DRUGPlacebo
Dummy treatment
Sponsors
AIXIAL Development
Unither Pharmaceuticals, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Onset of pain relief (versus 1000 mg of the reference oral paracetamol (Panadol®)). | 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? |
| Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®) | At 60 minutes | — |
| Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min) | 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 |
| Onset of pain relief (versus 500 mg of the reference oral paracetamol (Panadol®) | 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? |
| Proportion of responder patients at 60 minutes (versus 500 mg of the reference oral paracetamol (Panadol®)). | At 60 minutes | A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Period of time before taking rescue analgesic treatment intake. | Up to 24 hours after dose | — |
| Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®) | At 60 minutes | — |
| Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®) | At 360 minutes | — |
| Proportion of patients taking a rescue analgesic treatment. | At 6 hours | — |
| 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). | 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. |
| Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)). | At 60 minutes | 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. | 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and severity of serious and non-serious Adverse Events (AEs). | Up to 24 hours after dose | — |
| The test volume formulation acceptability | At 6 hours | Patients will answer a question enquiring about the satisfaction with the new oromucosal solution in terms of solution volume |
Countries
France, Italy, Poland, Spain
Outcome results
None listed