Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00281684 | SB-705498 Dental Pain Study After Tooth Extraction | PHASE2 | COMPLETED | 145 | — | — | Dec 7, 2005 | Oct 3, 2007 | Jan 28, 2019 | 5 | Italy, South Korea +1 |
Pain intensity was assessed using VAS. These assessments were then summarized to give a weighted mean score. The VAS was a subjective assessment of post-operative pain intensity. The participants rated the pain intensity at the time of assessment by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left (0 mm) indicated no pain and extreme right (100 mm) indicated worst pain imaginable. This scale has no subscales. Only those participants available at the specified time points were analyzed.
| Arm | Type | Description |
|---|---|---|
| Placebo | EXPERIMENTAL | Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days. |
| SB705498 400 mg | EXPERIMENTAL | Eligible participants received a single dose of SB705498 400 milligram (mg) capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days. |
| SB705498 1000 mg | EXPERIMENTAL | Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days. |
| Co-Codamol | EXPERIMENTAL | Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days. |
| Name | Type | Description |
|---|---|---|
| SB705498 400 mg | DRUG | SB705498 400 mg |
| SB705498 1000 mg | DRUG | SB705498 1000 mg |
| Placebo | DRUG | Placebo |
| Co-Codamol | DRUG | Co-Codamol |
Inclusion criteria: * Female or male subjects aged 18 to 50. Women may be of child bearing potential or of non-child bearing potential. Women of child bearing potential must use an effective method of contraception (see below). * Females of non-child bearing potential are defined as: * Post-menopau...