Postoperative analgesia MedDRA version: 9.1 Level: LLT Classification code 10036276 Term: Postoperative analgesia
Conditions
Interventions
Product Name: Org 28611
Product Code: Org 28611
Pharmaceutical Form: Solution for injection
CAS Number: 639068-77-2
Current Sponsor code
Sponsors
NV Organon
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Has at least one mandibular partial or full bony impacted third molar requiring extraction. An ipsilateral maxillary third molar may also be extracted as may any adjacent supernumerary tooth (teeth). 2. Is willing and able to understand and complete the pain evaluations 3. Is male aged 18 to 40 years (inclusive) 4. Has a body mass index (BMI) = 32 kg/m2 and a body weight of at least 65 kg. 5. Is in generally good health 6. Is able to speak, read, and understand English and provide meaningful written informed consent 7. Is able to remain at the research center for the entire 24-hour trial period 8. Has an initial pain intensity score of at least 45-mm on a 100-mm VAS and moderate or severe pain on a 4-point categorical scale within 6 hours of the end of surgery (VAS as the primary parameter and the categorical as a secondary parameter) 9. Is willing to return to the research center for the post-treatment visit 5 to 9 days after surgery and complete a 30 day SAE telephone call. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has uncontrolled or clinically significant cardiovascular, respiratory, gastrointestinal, renal, hepatic, metabolic, hematological, or immunological disease 2. Has a history of seizures, a family history of seizure disorder, or psychotic illness 3. Has a known allergy or significant adverse reaction to opioids or opioid antagonists paracetamol or ibuprofen 4. Has a history of chronic opioid or cannabis use or abuse within 6 months prior to the start of this trial 5. Has a positive urine drug test at screening or prior to surgery 6. Has participated in a trial of an investigational drug or device within 30 days prior to the trial 7. Has taken any of the following drugs within 4 hours or 5 elimination half-lives (whichever is greater) prior to dosing: aspirin, acetaminophen (paracetamol), nonsteroidal anti-inflammatory drugs (NSAIDs, COX-2 inhibitors), opioids, opioid combination drugs, sedative-hypnotics, muscle relaxants, and/or sedating antihistamines 8. Has taken a long-acting analgesic (e.g., naproxen or celecoxib), central nervous system (CNS) depressant, or alcohol (in any form) within 12 hours prior to dosing 9. Has taken a monoamine oxidase (MAO) inhibitor or tricyclic antidepressant drug within 4 weeks prior to administration of trial medication 10. Has taken a selective serotonin or norepinephrine reuptake inhibitor (SSRI or SNRI) within 4 weeks prior to the start of the trial 11. Has a medical or psychiatric condition which compromises the patient’s ability to give informed consent or appropriately complete the pain assessments 12. Has an abnormal EEG at the screening 13. Has had alcohol or caffeine in any form during 24 hours before dosing 14. Has abnormal laboratory results at the screening which in the opinion of the investigator are exclusionary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To compare the analgesic efficacy of a single IV dose of Org 28611 3.0 µg/kg to morphine sulfate 0.12 mg/kg in patients experiencing acute postoperative pain after dental impaction surgery 2. To assess the safety and tolerability of Org 28611 3.0 µg/kg compared to morphine 0.12 mg/kg and to placebo 3. To characterize the pharmacokinetic (PK) profile of Org 28611 when administered to patients experiencing acute postoperative pain after dental impaction surgery. ;Main Objective: To compare the analgesic efficacy of a single IV dose of Org 28611 3.0 µg/kg to placebo in patients experiencing acute postoperative pain after dental impaction surgery.;Primary end point(s): Total pain relief over the 0 – 4 hour interval (TOTPAR0-4hr). | — |
Countries
United Kingdom
Outcome results
None listed