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| Name | Class |
|---|---|
| AIXIAL Development | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol UNIFLASH 125mg | Experimental | 1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule |
|
| Placebo | Placebo Comparator | 1 Placebo sachet + 2 placebo capsule |
|
| Paracetamol 500mg | Active Comparator | 1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg |
|
| Paracetamol 1000mg | Active Comparator | 1 Placebo sachet + 2 capsules Panadol 500mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol Uniflash 125mg | Drug | Oromucosal solution 1.25 mL for buccal use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 60 minutes |
| 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?" | At 60 minutes |
| 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. | At 60 minutes |
| Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®) | At 60 minutes | |
| 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?" | At 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of serious and non-serious Adverse Events (AEs). | Up to 24 hours after dose | |
| The test volume formulation acceptability | Patients will answer a question enquiring about the satisfaction with the new oromucosal solution in terms of solution volume |
Inclusion Criteria:
Additional inclusion criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33075 | France | |||
| CHRU de Clermont Ferrand |
At this stage, IPD sharing plan has to been discussed and finalised
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 18, 2024 | |
| Reset | Jul 18, 2024 | |
| Release | Oct 30, 2024 |
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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.
| 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 |
|
| At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, and 6 hours. |
| 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. | At 60 minutes |
| 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. | At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours. |
| 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. | At 1 hour, 2 hours, 4 hours and 6 hours. |
| Period of time before taking rescue analgesic treatment intake. | Up to 24 hours after dose |
| Proportion of patients taking a rescue analgesic treatment. | At 6 hours |
| 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 |
| At 6 hours |
| Clermont-Ferrand |
| 63003 |
| France |
| Hôpital Louis Mourier | Colombes | 92700 | France |
| CHU Montpellier | Montpellier | 34070 | France |
| CHU de Strasbourg | Strasbourg | France |
| Università degli Studi di Milano | Milan | Italy |
| Department of maxilla facial Surgery -University of Udine | Udine | Italy |
| University Central Stomatology GDANSK | Gdansk | Poland |
| Oral Surgery Department, Central Clinical Hospital | Lodz | 92213 | Poland |
| Dental Practice | Lodz | Poland |
| Oral surgery Medical University of Lublin | Lublin | Poland |
| AW Clinic | Warsaw | Poland |
| NZOZ Akademicka Poliklinika Stomatologiczna | Wroclaw | 50425 | Poland |
| Centro Médico Teknon - Grupo Quironsalud | Barcelona | 08022 | Spain |
| Hospital Odontológico Universitat Barcelona | Barcelona | Spain |
| Facultad de Odontología de la Universidad de Granada | Granada | Spain |
| Instituto Profesor Sada | Madrid | Spain |
| Faculty of Medicine of the UNIVERSITY OF MURCIA | Murcia | 30003 | Spain |
| Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| Reset | Dec 19, 2024 |
| Release | Apr 28, 2026 |
| Reset | May 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 18, 2024 | Jul 18, 2024 | |||
| Oct 30, 2024 | Dec 19, 2024 | |||
| Apr 28, 2026 | May 22, 2026 |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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