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. - Paramouth

ITHER PHARMACEUTICALS0 sites404 target enrollmentJune 7, 2021

DrugsPanadol

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ITHER PHARMACEUTICALS
Enrollment: 404
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 7, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ITHER PHARMACEUTICALS

Eligibility Criteria

Inclusion Criteria

•1\. Male and female patient aged from 18 years of age at the time of signing the informed consent;
•2\. Patient 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 (e.g., mepivacaine or lidocaine) preoperatively;
•3\. Patient weighing \> 50 kg;
•4\. Female patient of childbearing potential must be willing to use a highly efficient birth control method during the study;
•A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
•The following are considered as highly effective birth control methods:
•Established use of oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation \- Established use of oral, injected, or implanted progestogen\-only hormonal contraception associated with inhibition of ovulation – Intrauterine hormone\-releasing system or placement of an intrauterine device – Bilateral tubal occlusion – Vasectomised partner \- True abstinence \[periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception].
•5\. Patient able to understand and comply with protocol requirements and instructions;
•6\. Patient covered by national healthcare insurance system or similar system, if applicable by local regulations;
•7\. Patient who has signed a written informed consent obtained prior to any study\-related procedures.

Exclusion Criteria

•1\. Patient who undergoes an extraction of contralateral molar in the same procedure or a bony\-impacted molar;
•2\. Patient 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);
•3\. 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;
•4\. Patient with any known hypersensitivity to paracetamol, ibuprofen or ingredients contained in Investigational Medicinal Products (IMP) and Non\-Investigational Medicinal Products (NIMP);
•5\. Patient with contra\-indication to the alcoholic solution for medical reason (alcoholic weaning or abuse, epilepsy);
•6\. Women with positive results on a urine pregnancy test or breastfeeding women or women of childbearing potential without an effective contraception;
•7\. Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities;
•8\. Patient with a current or chronic history of severe renal impairment;
•9\. Patient with severe heart failure (New York Heart Association (NYHA) Class IV);
•10\. Patient with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;