E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Men and women who are to undergo elective surgery for extraction of at least one lower impacted or partially impacted third molar |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLTn |
E.1.2 | Classification code | 10059723 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 < systolic blood pressure (SBP) < 140 mmHg, • 50 mmHg < diastolic blood pressure (DBP) < 90 mmHg, • 40 bpm < heart rate (HR) < 100 bpm. Normal automatic 12- lead electrocardiogram (ECG): • 120 ms < PR < 220 ms, • QRS < 120 ms, • QTc < or = 430 ms in male, < or = 450 ms in female, • Incomplete right bundle branch block can be accepted. Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine and hepatic enzymes (AST, ALT) should be strictly below the upper laboratory norm. Female : Using a double contraception method according to the following algorithm: [intrauterine device or hormonal contraception or condom] plus [diaphragm or spermicide], except if postmenopausal for more than 12 months or sterilized for more than 3 months. |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Analgesic effect: (SPID0-8) summed, time-weighted pain intensity differences (PIDs) from baseline to 8 hours per dose. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |