A randomized, double-blind, active and placebo controlled trial to compare the relative analgesic efficacy and safety of a single intravenous dose of Org 28611 3.0 µg/kg, morphine sulfate 0.12 mg/kg, and placebo in patients experiencing moderate to severe pain after dental impaction surgery
- Conditions
- Postoperative analgesiaMedDRA version: 9.1 Level: LLT Classification code 10036276 Term: Postoperative analgesia
- Registration Number
- EUCTR2006-002571-40-GB
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 132
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: 1. To compare the analgesic efficacy of a single IV dose of Org 28611 3.0 µg/kg to morphine sulfate<br> 0.12 mg/kg in patients experiencing acute postoperative pain after dental impaction surgery<br> 2. To assess the safety and tolerability of Org 28611 3.0 µg/kg compared to morphine<br> 0.12 mg/kg and to placebo<br> 3. To characterize the pharmacokinetic (PK) profile of Org 28611 when administered to patients<br> experiencing acute postoperative pain after dental impaction surgery.<br> ;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).
- Secondary Outcome Measures
Name Time Method