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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04622735
Other study ID # UP-CLI-2019-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 22, 2020
Est. completion date October 20, 2022

Study information

Verified date November 2022
Source Unither Pharmaceuticals, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 321
Est. completion date October 20, 2022
Est. primary completion date October 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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): 1. 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, 2. 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),

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
nefopam hydrochloride 30mg / paracetamol 500mg X2
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.
Drug:
Paracetamol 500 Mg Oral Tablet X2
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 X2
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.

Locations

Country Name City State
Belgium Hôpital Leuven Leuven
France CHU Angers Angers
France CHU Marseille Marseille
France Centre Hospitalier de Pontoise Pontoise
France HIA Toulon Toulon
France CHU de tours Tours
Hungary Clinexpert Kft. Budapest
Hungary Óbudai Egészségügyi Centrum Budapest
Hungary Swan-Med Kft. Letavertes
Hungary Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Nyíregyháza
Hungary Szent Borbála Kórház, Tatabánya
Hungary Óbudai Egészségügyi Centrum Zalaegerszeg
Russian Federation LLC Center for interdisciplinary dentistry & neuro Moscow
Russian Federation State Medico-stomato Univ., by A.I. Evdokimov Moscow
Russian Federation Regional clinical hospital Yaroslavl
United Kingdom Birmingham School of Dentistry Birmingham
United Kingdom University Dental Hospital Cardiff
United Kingdom Edinburgh Dental Institute Edinburgh
United Kingdom BARTS HEALTH NHS TRUST Royal London Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Unither Pharmaceuticals, France EXCELYA Bordeaux

Countries where clinical trial is conducted

Belgium,  France,  Hungary,  Russian Federation,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Occurrence and severity of adverse events (serious and non-serious adverse events). Up to 10 days after first dose
Primary Ranked endpoints : 1. Sum of Pain Intensity Differences at 6 hours (SPID0-6h) Pain intensity difference 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 IMP intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (VAS) compared to baseline. 6 hours post-dose
Primary 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). 6 hours post-dose
Primary Proportion of responder patients A responder patient is a subject who achieves a reduction of 50% of pain intensity compared to baseline. 6 hours post-dose
Primary The Patient's Global Impression of Change (PGIC) questionnaire 6 hours post-dose
Primary 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. during the first 6 hours
Secondary 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 At 1 hour, 2 hours, 3 hours, and 4 hours
Secondary 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. At 1 hour, 2 hours, 3 hours, and 4 hours
Secondary The Pain Intensity Differences (PID) assessment PID will be calculated using the scores of pain intensity (VAS) at each time point compared to baseline. At each timepoint: 30min, At 45min, until at 360 min post-dose
Secondary Proportion of responder patients. At 1 hour, 2 hours, 3 hours and 4 hours.
Secondary Time to the second IMP intake Up to 5 days after first dose
Secondary Time to rescue medication intake Up to 10 days after first dose
Secondary Sum of Pain Intensity Differences (SPID) 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. At days 1, 2, 3, 4 and 5
Secondary Proportion of patients having taken a rescue analgesic treatment throughout the study. Up to 10 days after first dose
Secondary The total dose of rescue medication taken. Up to 10 days after first dose
Secondary Mean duration under rescue medication over the 5 days. Up to 5 days after first dose
Secondary Number of IMP intakes Up to 5 days after first dose
Secondary Patient's Global Impression of Change (PGIC) score Up to 10 days after first dose
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