Acute PainPhase 3NCT04622735
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction
A Phase 3 study testing nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2 and Nefopam HCl 30 MG Oral Tablet X2 in people with Acute Pain, run by Unither Pharmaceuticals, France at 19 sites in 5 countries.
Trial summary
This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2 and Nefopam HCl 30 MG Oral Tablet X2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 22 Feb 2020to 20 Oct 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Male and female patient aged from 18 years up to 65 years,
- Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,
- Patient weighing > 50 kg,
- Patient who has signed a written informed consent prior to any study-related procedures.
Additional inclusion criteria after surgery (randomization):
- Patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 50 mm,
- Third molar extraction(s) 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)
Main Exclusion Criteria:
- Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,
- Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,
- Patient with a history of convulsive disorders,
- Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),
- Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,
- Patient with known anaemia,
- Patient with known pulmonary disease,
- Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,
- Patient with known glaucoma,
- Patients with a prostatic hyperplasia or urinary retention,
- Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,
- Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
Hungary6 sites
Clinexpert Kft.
Budapest
Óbudai Egészségügyi Centrum
Budapest
Swan-Med Kft.
Létavértes
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház,
Nyíregyháza
Szent Borbála Kórház,
Tatabánya
Óbudai Egészségügyi Centrum
Zalaegerszeg
France5 sites
CHU Angers
Angers, 49933
CHU Marseille
Marseille, 13385
Centre Hospitalier de Pontoise
Pontoise, 95300
HIA Toulon
Toulon, 83800
CHU de tours
Tours, 37170
United Kingdom4 sites
Birmingham School of Dentistry
Birmingham, B5 7EG
University Dental Hospital
Cardiff, CF14 4XY
Edinburgh Dental Institute
Edinburgh, EH3 9HX
BARTS HEALTH NHS TRUST Royal London Hospital
London, E1 1FR
Russia3 sites
LLC Center for interdisciplinary dentistry & neuro
Moscow, 141207
State Medico-stomato Univ., by A.I. Evdokimov
Moscow
Regional clinical hospital
Yaroslavl, 150062
About this study
Official title: A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction
This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.
- Conditions
- Acute Pain
- Being tested
- nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2, Nefopam HCl 30 MG Oral Tablet X2
- Keywords
- Moderate to severe acute pain, Postoperative pain, Third molar extraction, Analgesics, Nefopam, Paracetamol, Multimodal analgesia, Fixed drug combination
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nefopam hydrochloride 30mg / paracetamol 500mg X2Combination product
The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
Paracetamol 500 Mg Oral Tablet X2Drug
Also called Acetaminophen
The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
Nefopam HCl 30 MG Oral Tablet X2Drug
The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
| Study group | Role | What they receive |
|---|---|---|
| FDC nefopam hydrochloride 30 mg / paracetamol 500 mg (X2) | Experimental | Each dose: 2 tablets (included in masking capsule) Receives: Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2 |
| Paracetamol 500 mg (X2) | Active comparator | Each dose: 2 tablets (included in masking capsule) Receives: Drug: Paracetamol 500 Mg Oral Tablet X2 |
| Nefopam hydrochloride 30 mg (X2) | Active comparator | Each dose: 2 tablets (included in masking capsule) Receives: Drug: Nefopam HCl 30 MG Oral Tablet X2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)
Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline.
Calculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product
SPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) * (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score
Measured: 6 hours post-dose
Total Pain Relief at 6 Hours (TOTPAR0-6h)
Pain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS).
Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) * (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome
Measured: 6 hours post-dose
Proportion of Responder Patients
A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline.
Measured: 6 hours post-dose
The Patient's Global Impression of Change (PGIC) Questionnaire
Measured: 6 hours post-dose
The Onset of Pain Relief
Score of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief.
Measured: during the first 6 hours
Secondary outcomes (12)
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
Pain relief (PAR) will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale
Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) * (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-any time = 0 TOTPAR max 0-1h = 300 ; TOTPAR max 0-2h = 600 ;TOTPAR max 0-3h = 900 ;TOTPAR max 0-4h = 1200 ; The higher score mean a better outcome
Measured: At 1 hour, 2 hours, 3 hours, and 4 hours
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240 min) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline.
Calculation: SPID is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first IMP
SPID0-4h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) * (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-1h = 6000 ; SPID max 0-2h = 12000; SPID max 0-3h = 18000; SPID max 0-4h = 24000 The lower score mean a better score
Measured: At 1 hour, 2 hours, 3 hours, and 4 hours
The Pain Intensity Differences (PID) Assessment
PID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline.
PID30min = VAS of pain intensity 30min - VAS of pain intensity baseline PID min = 0 / PID max = 100 A higher PID is a better outcome
Measured: At each timepoint: 30min, At 45min, until at 360 min post-dose
Proportion of Responder Patients.
Measured: At 1 hour, 2 hours, 3 hours and 4 hours.
Time to the Second Investigational Medicinal Product (IMP) Intake
Measured: Up to 5 days after first dose
Participant Having Taken a Rescue Analgesic Treatment
Measured: Up to 10 days after first dose
Sum of Pain Intensity Differences
Pain Intensity Difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points using a 100-mm visual Analog Scale (VAS) compared to baseline.
Calculation: Sum of Pain Intensity Difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product
With: SPIDTime1-Time2 = (VAS Theoretical Time1 + VAS Theoretical Time2) * (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-any time = 0 SPID max 0-day 1 = 144000 ; SPID max 0-day 2 = 288000 ; SPID max 0-day 3 = 432000 ; SPID max 0-day 4 = 576000 ; SPID max 0-day 5 = 720000 ; The lower score means a better outcome
Measured: At days 1, 2, 3, 4 and 5
Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.
Measured: Up to 10 days after first dose
The Total Dose of Rescue Medication Taken.
Measured: Up to 10 days after first dose
Mean Duration Under Rescue Medication Over the 5 Days.
Measured: Up to 5 days after first dose
Number of Investigational Medicinal Product (IMP) Intakes
Measured: Up to 5 days after first dose
Patient's Global Impression of Change (PGIC) Score
Measured: Up to 10 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start22 Feb 2020
- Primary completion12 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unither Pharmaceuticals, France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Excelya
- Responsible party
- Sponsor
- Investigators
- International Study Coordinator, Principal investigator, Birmingham School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622735
- Sponsor's protocol ID
- UP-CLI-2019-002
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2020
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction
- ClinicalTrials.gov ID
- NCT04622735
- Acronym / sponsor ID
- UP-CLI-2019-002
- Conditions
- Acute Pain
- Keywords
- Moderate to severe acute pain, Postoperative pain, Third molar extraction, Analgesics, Nefopam, Paracetamol, Multimodal analgesia, Fixed drug combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
- Collaborators
- Excelya
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 10 Nov 2020 (actual)
- Results
- Posted 27 Nov 2024
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 and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FDC nefopam hydrochloride 30 mg / paracetamol 500 mg (X2) | Experimental | Combination Product: nefopam hydrochloride 30mg / paracetamol 500mg X2Each dose: 2 tablets (included in masking capsule) |
| Paracetamol 500 mg (X2) | Active comparator | Drug: Paracetamol 500 Mg Oral Tablet X2Each dose: 2 tablets (included in masking capsule) |
| Nefopam hydrochloride 30 mg (X2) | Active comparator | Drug: Nefopam HCl 30 MG Oral Tablet X2Each dose: 2 tablets (included in masking capsule) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| nefopam hydrochloride 30mg / paracetamol 500mg X2The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. | Combination product | FDC nefopam hydrochloride 30 mg / paracetamol 500 mg (X2) |
| Paracetamol 500 Mg Oral Tablet X2Also: AcetaminophenThe first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. | Drug | Paracetamol 500 mg (X2) |
| Nefopam HCl 30 MG Oral Tablet X2The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day. | Drug | Nefopam hydrochloride 30 mg (X2) |
Primary outcome
Ranked Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h)
Time frame: 6 hours post-dose
Pain intensity difference (PID) will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first Investigational Medicinal Product (IMP) intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline. Calculation: Sum of Pain intensity difference (SPID) is the time-weighted summary measure of the total area under the pain intensity difference (PID) curve that integrates serial assessments of pain during x times after the first Investigational Medicinal Product SPID0-6h= SPID0-30min+SPID30min-45min+SPID45min-1h+SPID1h-1h30+SPID1h30-2h+SPID2h-2h30+SPID2h30-3h+SPID3h-4h+SPID4h-5h+SPID5h-6h With: SPIDTime1-Time2 = (PID Theoretical Time1 + PID Theoretical Time2) * (Theoretical Time2- Theoretical Time1) / 2 SPID min 0-6h = 0 SPID max 0-6h = 36000 The lower score mean a better score
Total Pain Relief at 6 Hours (TOTPAR0-6h)
Time frame: 6 hours post-dose
Pain Relief will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) after the first IMP intake and/or right before first intake of rescue medication using a 5-point verbal rating scale (VRS). Calculation: TOTPAR is the time-weighted summary measure of the total area under the pain release difference curve that integrates serial assessments of pain release during x times after the first Investigational Medicinal Product TOTPAR0-6h=TOTPAR0-30min+TOTPAR30min-45min+TOTPAR45min-1h+TOTPAR1h-1h30+TOTPAR1h30-2h+TOTPAR2h-2h30+TOTPAR2h30-3h+ TOTPAR 3h-4h+ TOTPAR 4h-5h+ TOTPAR 5h-6h With: TOTPARTime1-Time2 = (PAR Time1 + PAR Time2) * (Time2-Time1) / 2 And with the score of pain relief at T0 = 0 ("none") TOTPAR min 0-6h = 0 TOTPAR max 0-6h = 1800 The higher score mean a better outcome
Proportion of Responder Patients
Time frame: 6 hours post-dose
A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline.
The Patient's Global Impression of Change (PGIC) Questionnaire
Time frame: 6 hours post-dose
The Onset of Pain Relief
Time frame: during the first 6 hours
Score of pain intensity will be assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min). The time point of the first assessment obtaining a score ≤ 30 mm will be retained as time score of onset of pain relief.
12 secondary outcomes
Total Pain Relief at 1 Hour (TOTPAR0-1h), 2 Hours (TOTPAR0-2h), 3 Hours (TOTPAR0-3h), and 4 Hours (TOTPAR0-4h)
Time frame: At 1 hour, 2 hours, 3 hours, and 4 hours
Sum of Pain Intensity Differences at 1 Hour (SPID0-1h), 2 Hours (SPID0-2h), 3 Hours (SPID0-3h), and 4 Hours (SPID0-4h)
Time frame: At 1 hour, 2 hours, 3 hours, and 4 hours
The Pain Intensity Differences (PID) Assessment
Time frame: At each timepoint: 30min, At 45min, until at 360 min post-dose
Proportion of Responder Patients.
Time frame: At 1 hour, 2 hours, 3 hours and 4 hours.
Time to the Second Investigational Medicinal Product (IMP) Intake
Time frame: Up to 5 days after first dose
Participant Having Taken a Rescue Analgesic Treatment
Time frame: Up to 10 days after first dose
Sum of Pain Intensity Differences
Time frame: At days 1, 2, 3, 4 and 5
Proportion of Patients Having Taken a Rescue Analgesic Treatment Throughout the Study.
Time frame: Up to 10 days after first dose
The Total Dose of Rescue Medication Taken.
Time frame: Up to 10 days after first dose
Mean Duration Under Rescue Medication Over the 5 Days.
Time frame: Up to 5 days after first dose
Number of Investigational Medicinal Product (IMP) Intakes
Time frame: Up to 5 days after first dose
Patient's Global Impression of Change (PGIC) Score
Time frame: Up to 10 days after first dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
International Study Coordinator principal investigator
Birmingham School of Dentistry
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nefopam hydrochloride 30mg / paracetamol 500mg X2, Paracetamol 500 Mg Oral Tablet X2 and Nefopam HCl 30 MG Oral Tablet X2 in people with Acute Pain, run by Unither Pharmaceuticals, France at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Hungary, France, United Kingdom, Russia, Belgium. 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. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Endpoints : 1. Sum of Pain Intensity Differences at 6 Hours (SPID0-6h) (time frame: 6 hours post-dose). 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 27 Nov 2024.