Acute PainPhase 3NCT04640376
Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction
A Phase 3 study testing Paracetamol Uniflash 125mg, Panadol 500 MG Oral Tablet X1 and Panadol 500 MG Oral Tablet X2 in people with Acute Pain, run by Unither Pharmaceuticals, France at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Paracetamol Uniflash 125mg, Panadol 500 MG Oral Tablet X1 and Panadol 500 MG Oral Tablet X2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 24 Mar 2021to 10 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Spain7 sites
Centro Médico Teknon - Grupo Quironsalud
Barcelona, 08022
Hospital Odontológico Universitat Barcelona
Barcelona
Facultad de Odontología de la Universidad de Granada
Granada
Instituto Profesor Sada
Madrid
Faculty of Medicine of the UNIVERSITY OF MURCIA
Murcia, 30003
Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, 15706
Hospital Universitario Virgen del Rocio
Seville
Poland6 sites
University Central Stomatology GDANSK
Gdansk
Oral Surgery Department, Central Clinical Hospital
Lodz, 92213
Dental Practice
Lodz
Oral surgery Medical University of Lublin
Lublin
AW Clinic
Warsaw
NZOZ Akademicka Poliklinika Stomatologiczna
Wroclaw, 50425
France5 sites
CHU de Bordeaux
Bordeaux, 33075
CHRU de Clermont Ferrand
Clermont-Ferrand, 63003
Hôpital Louis Mourier
Colombes, 92700
CHU Montpellier
Montpellier, 34070
CHU de Strasbourg
Strasbourg
Italy2 sites
Università degli Studi di Milano
Milan
Department of maxilla facial Surgery -University of Udine
Udine
About this study
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.
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
- Being tested
- Paracetamol Uniflash 125mg, Panadol 500 MG Oral Tablet X1, Panadol 500 MG Oral Tablet X2, Placebo
- Keywords
- paracetamol
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol Uniflash 125mgDrug
Oromucosal solution 1.25 mL for buccal use
Panadol 500 MG Oral Tablet X1Drug
Tablet masked in capsule
Panadol 500 MG Oral Tablet X2Drug
Tablet masked in capsule
PlaceboDrug
Dummy treatment
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol UNIFLASH 125mg | Experimental | 1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule Receives: Drug: Paracetamol Uniflash 125mg; Drug: Placebo |
| Placebo | Placebo comparator | 1 Placebo sachet + 2 placebo capsule Receives: Drug: Placebo |
| Paracetamol 500mg | Active comparator | 1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg Receives: Drug: Panadol 500 MG Oral Tablet X1; Drug: Placebo |
| Paracetamol 1000mg | Active comparator | 1 Placebo sachet + 2 capsules Panadol 500mg Receives: Drug: Panadol 500 MG Oral Tablet X2; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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?"
Measured: 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.
Measured: At 60 minutes
Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®)
Measured: 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?"
Measured: At 60 minutes
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 1 hour, 2 hours, 4 hours and 6 hours.
Period of time before taking rescue analgesic treatment intake.
Measured: Up to 24 hours after dose
Proportion of patients taking a rescue analgesic treatment.
Measured: At 6 hours
Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)
Measured: At 60 minutes
Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)
Measured: At 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start24 Mar 2021
- Primary completion8 Nov 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AIXIAL Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640376
- Sponsor's protocol ID
- UP-CLI-2020-001
- Status last verified
- Oct 2022
- First submitted
- 16 Nov 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, IPD sharing plan has to been discussed and finalised
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04640376
- Acronym / sponsor ID
- UP-CLI-2020-001
- Conditions
- Acute Pain
- Keywords
- paracetamol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Collaborators
- AIXIAL Development
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paracetamol UNIFLASH 125mg | Experimental | Drug: Paracetamol Uniflash 125mg, Drug: Placebo1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule |
| Placebo | Placebo comparator | Drug: Placebo1 Placebo sachet + 2 placebo capsule |
| Paracetamol 500mg | Active comparator | Drug: Panadol 500 MG Oral Tablet X1, Drug: Placebo1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg |
| Paracetamol 1000mg | Active comparator | Drug: Panadol 500 MG Oral Tablet X2, Drug: Placebo1 Placebo sachet + 2 capsules Panadol 500mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol Uniflash 125mgOromucosal solution 1.25 mL for buccal use | Drug | Paracetamol UNIFLASH 125mg |
| Panadol 500 MG Oral Tablet X1Tablet masked in capsule | Drug | Paracetamol 500mg |
| Panadol 500 MG Oral Tablet X2Tablet masked in capsule | Drug | Paracetamol 1000mg |
| PlaceboDummy treatment | Drug | Paracetamol 1000mg, Paracetamol 500mg, Paracetamol UNIFLASH 125mg, Placebo |
Primary outcome
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
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?"
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.
Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®)
Time frame: At 60 minutes
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?"
8 secondary outcomes
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.
Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)).
Time frame: At 60 minutes
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.
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.
Period of time before taking rescue analgesic treatment intake.
Time frame: Up to 24 hours after dose
Proportion of patients taking a rescue analgesic treatment.
Time frame: At 6 hours
Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)
Time frame: At 60 minutes
Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)
Time frame: At 360 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No. At this stage, IPD sharing plan has to been discussed and finalised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol Uniflash 125mg, Panadol 500 MG Oral Tablet X1 and Panadol 500 MG Oral Tablet X2 in people with Acute Pain, run by Unither Pharmaceuticals, France at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Poland, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min) (time frame: At 60 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.