Postoperative dental pain MedDRA version: 20.0 Level: PT Classification code 10036276 Term: Postoperative analgesia System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: CR4056 150 mg
Product Code: CR4056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N02
CAS Number: 1004997-71-0
Current Sponsor code: CR4056
Other descriptive name: Quinazoline,
Sponsors
Rottapharm Biotech s.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent obtained before undergoing any trial-specific procedure. 2. Male or female aged =18 and =65 years, in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests. 3. Body Mass Index>18.5 and =35 kg/m2. 4. Planned elective dental surgical procedure consisting in the extraction of a mandibular third molar with partial or complete bone impaction (with Class II or III, position B or C using Pell and Gregor classification as confirmed by presurgery x-ray available in the patient file as source data). Concomitant extraction of the ipsilateral maxillary third molar is also accepted (while concomitant extractions of any contralateral tooth or any other dental surgical procedure is NOT accepted). 5. Willingness and capability to comply with the scheduled study visits, treatment plan and study procedures (e.g. completion of the e-diary). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1. History of cardiovascular or cerebrovascular disease or presence of known significant risk factors for cardiovascular events. 2. History/known presence of coagulation or hematopoietic disease. 3. History/known presence of gastric/duodenal ulcers, gastrointestinal bleeding and inflammatory bowel diseases. 4. History/known presence or family history of malignant hyperthermia or anaesthesia-related events. 5. History of hypersensitivity to sulphonamides or other drugs. 6. Known allergy/hypersensitivity to the study drugs, or to any of their excipients. 7. History/known presence of hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (the study drugs contain lactose). 8. History of alcohol or drug (including analgesics) abuse =12 months before the screening visit. 9. Known surgical or medical condition of the GI, hepatic, or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance. 10. Any other known clinically relevant disease that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the patient’s safety during trial participation. 11. Serum alkaline-phosphatase, or gamma-glutamyl-transferase, or lipase greater than 3-fold the upper limit of normal (ULN); alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN. 12. Creatinine clearance <30 ml/min. 13. Any other laboratory examination performed at screening with clinically relevant findings, as judged by the Investigator. 14. 12-lead ECG with clinically relevant findings, as judged by the Investigator. 15. Contraindications for use of single dose celecoxib (see Celebrex® SmPC). 16. Contraindications for use of paracetamol (see Tachipirina® SmPC). 17. Use of drugs active on Central Nervous System (CNS) that cannot be withhold at least 7 days before randomization and until 24 h after the administration of the study drug. 18. Use of antithrombotic drugs, such as acetyl salicylic acid (oral doses =325 mg/day) or of other antiplatelet/anticoagulant drugs (including warfarin, heparin, rivaroxaban, and dabigatran) for the primary and secondary prevention of cardiovascular events that cannot be withhold at least 7 days before randomization and until 24 h after the administration of the study drug. 19. Use of drugs interacting with CYP450 enzymes that cannot be withhold at least 7 days before randomization and until 24 h after the administration of the study drug. 20. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, before screening. 21. Difficulty in swallowing capsules/tablets. 22. Pregnant or lactating women. 23. Women of childbearing potential who do not agree to practice an effective method of contraception from the enrolment up to 30 days after Investigational Medicinal Product (IMP) intake. 24. Fertile men with a female partner of childbearing potential who do not agree to use a condom from the enrolment up to 7 days after the IMP intake. 25. Any other condition that, in the opinion of the Investigator, may jeopardize the study conduct according to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the analgesic efficacy of a single dose of CR4056 in patients with postoperative dental pain;Secondary Objective: To assess the safety and tolerability of a single dose of CR4056 in patients with postoperative dental pain;Primary end point(s): Summed, time-weighted Pain Intensity Difference (SPID) over 8 h after study drug administration (SPID8) using the 4-point categorical scale;Timepoint(s) of evaluation of this end point: Over 8 h after study drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Summed time-weighted Pain Intensity Difference (SPID) using the 4-point categorical scale 2. SPID using the 100 mm VAS 3. TOTal PAin Relief (TOTPAR) 4. Pain Intensity Difference (PID) using both the 4-point categorical scale and the 100 mm VAS 5. Pain relief (PR) 6. Summed, time-weighted PRID (sum of PID and PR scores) (SPRID) using the categorical scales 7. Patient’s Global Evaluation of the study drug 8. Onset of analgesia as time to Perceptible PR and time to Meaningful PR 9. Maximum PID (peak-PID) using both the 4-point categorical scale and the 100 mm VAS 10. Maximum PR 11. Percentage of patients taking rescue analgesic medication 12. Time-to-first rescue analgesic medication use 13. Safety;Timepoint(s) of evaluation of this end point: 1. Over 4, 6, 12, 24 after study drug administration 2. Over 4, 6, 8, 12, 24 after study drug administration 3. Over 4, 6, 8, 12, 24 after study drug administration 4. at different time points up to 24 h post dose 5. at the different time points up to 24 h post-dose 6. Over 4, 6, 8, 12, 24 h post-dose 7. 24 after study drug administration 8. Over 24 after study drug administration 9. during the first 8 h post-dose 10. during the first 8 h post-dose 11. Over 24 after study drug administration 12. Over 24 after study drug administration 13. Over 24 after study drug administration | — |
Countries
Poland
Contacts
Public ContactSenior Clinical Research Manager
Rottapharm Biotech s.r.l.
Outcome results
None listed