A Multi-centre, Randomised, Single Blind, Placebo Controlled, Parallel Group Study to Examine the Effect of Single Doses of SB-705498, a TRPV1 Receptor Antagonist, on Pain Following Third Molar Tooth Extraction
Overview
- Phase
- Phase 2
- Intervention
- SB705498 1000 mg
- Conditions
- Toothache
- Sponsor
- GlaxoSmithKline
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- Mean of Pain Intensity Based on the Visual Analogue Scale (VAS)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This clinical trial is a multi centre, randomised, single-blind, parallel group, placebo-controlled, single oral dose study with a positive control arm. Patients previously scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon completion of surgery, e.g. prior to established pain, patients will be randomised to treatment (SB-706598, placebo or co-codamol) and dosed with the study medication
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SB705498 1000 mg
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.
Intervention: SB705498 1000 mg
Placebo
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.
Intervention: Placebo
SB705498 400 mg
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.
Intervention: SB705498 400 mg
Co-Codamol
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.
Intervention: Co-Codamol
Outcomes
Primary Outcomes
Mean of Pain Intensity Based on the Visual Analogue Scale (VAS)
Time Frame: Up to 10 hours post-dose
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.
Secondary Outcomes
- Elapsed Time From Study Drug Administration to Rescue Analgesic Request(Within 24 hours of administration of study drug)
- Number of Participants With Different Global Evaluation or Overall Impression of Study Medication Use and at 10 and 24 Hours Post Randomization(Prior to first rescue medication use and at 10 and 24 hours post randomization)
- VAS Mean Pain Scores From the Time of Rescue Medication up to 10 Hours Post Randomization(From the time of rescue medication to 10 hours post randomization)
- Area Under Curve (AUC)(0-rescue) and AUC(0-t) of SB705498(At pre-dose on Baseline (Day 1) and at between 20-40 minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post dose and at final follow-up (Day 28))
- Plasma Concentrations: Average Concentration (C-avg) [0-rescue] and Maximum Concentration (C-max) of SB705498(At pre-dose on Baseline (Day 1) and at between 20-40 minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post dose and at final follow-up (Day 28))
- Time Prior to the First Measurable Concentration (T-lag) and Time to Maximum Observed Plasma Concentration (T-max)(At pre-dose (Baseline) and at between 20-40minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post randomization and at final follow-up (Day 28))
- Number of Participants With Adverse Events (AE) Over Time(Up to Follow-up (28 days))
- Number of Participants From First Rescue Medication Use to Second Rescue Analgesic Request(From first dose of rescue medication to second dose of rescue medication)
- Change From Baseline for Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)(Baseline (Day 1) to 24 hours post Baseline)
- Number of Participants With Abnormal Urine Parameters(Up to 28 days)
- Change From Baseline in the Pain Intensity Based on the Verbal Rating Scale (VRS) up to 10 Hours Post Baseline(Up to 10 hours post Baseline (Day 1))
- Change From Baseline in the Pain Intensity Based on the VAS up to 10 Hours Post-Baseline(Baseline (Day 1) to 10 hours post Baseline)
- Number of Participants Requiring Rescue Medication Over Time(Up to 10 hour post-dose)
- Number of Participants With Abnormal Electrocardiogram (ECG) Findings(28 days)
- Number of Participants With Second Degree Atrioventricular Block Over 24 Hours by Holter Tape(Up to 24 hours post-dose)
- Change From Baseline for Vital Signs-Body Temperature(Baseline (Day 1) to 24 hours post Baseline)
- Number of Participants With Clinical Chemistry/ Hematology Values/ Serum Hormones Values of Potential Clinical Concern(Up to 28 days)