Men and women who are to undergo elective surgery for extraction of at least one lower impacted or partially impacted third molar MedDRA version: 8.1 Level: LLTn Classification code 10059723
Conditions
Interventions
Product Name: SSR150106XB
Product Code: SSR150106XB
Pharmaceutical Form: Oral solution
INN or Proposed INN: NA
CAS Number: 335267-09-9
Sponsors
Sanofi-Synthelabo Recherche
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female patients, between 18 and 45 years of age. Body weight between 45 kg and 110kg, body mass index (BMI) between 18 and 30 kg per square metre Impacted or partially impacted third molar requiring surgical extraction. Score of at least 40 mm on a 100 mm VAS for pain intensity within 5 hours after the surgery. Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). Normal vital signs after 10 minutes resting in supine position: • 95 mmHg =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular or infectious disease; any acute infectious disease or signs of acute illness. Any history of blood dyscrasia or bleeding disorder. Frequent headaches and / or migraine, recurrent nausea and/or vomiting (more than twice a month). Blood donation within one month before administration. Symptomatic hypotension whatever the decrease in blood pressure or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within 3 minutes when changing from the supine to the standing position. Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician. History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day) Smoking more than 5 cigarettes or equivalent/day, unable to stop smoking during the study. Excessive consumption of beverages with xanthine bases (> 4 cups or glasses/day). Female: Pregnancy (defined as positive blood ß- HCG test) or breast- feeding. Any medication (including St John’s Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, with the exception of local anaesthetic, hormonal contraception or menopause hormone replacement therapy in female. Positive reaction to any of the following tests: HBs antigen, anti- HCV antibodies, anti- HIV1+ 2 antibodies. Positive results on urine drug screen (UDS) (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates). Positive alcohol breath test. Poor metabolizer for CYP2D6 (by genotyping).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of a single oral 120 µg dose of SSR150106XB on the intensity of post dental surgery pain as compared to placebo.; Secondary Objective: To assess the failure rate, the pain relief, the onset of action, and the duration of action as compared to placebo, Safety and tolerability of a single oral 120 µg dose of SSR150106XB, Pharmacokinetic assessment of SSR150106 and its metabolite SSR150655. ;Primary end point(s): Analgesic effect: (SPID0-8) summed, time-weighted pain intensity differences (PIDs) from baseline to 8 hours per dose. | — |
Countries
United Kingdom
Outcome results
None listed