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SB705498

Phase 2

Toothache | Small molecule | Other |GSK plc|Last Updated: Jan 28, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment145

FDA Designations

No designations recorded

Clinical trial landscape

SB705498 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00281684SB-705498 Dental Pain Study After Tooth ExtractionToothache
COMPLETED145 Analytics
PHASE2COMPLETED
SB-705498 Dental Pain Study After Tooth Extraction
ToothacheUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean of Pain Intensity Based on the Visual Analogue Scale (VAS)
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.

Measurement of the area of flare induced by capsaicin as assessed by Laser
1 hour
2) Average itch over maximum of 15 minutes post application of challenge agent
15 minutes

Secondary Endpoints

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
Elapsed Time From Study Drug Administration to Rescue Analgesic Request
Within 24 hours of administration of study drug
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Study Design & Arms

AllocationRANDOMIZED
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboEXPERIMENTALEligible 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 mgEXPERIMENTALEligible 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 mgEXPERIMENTALEligible 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-CodamolEXPERIMENTALEligible 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.
study populationEXPERIMENTALAll subjects will receive 1%, 3%, 5% (w/w) of SB705498 and a placebo comparator

Interventions

NameTypeDescription
SB705498 400 mgDRUGSB705498 400 mg
SB705498 1000 mgDRUGSB705498 1000 mg
PlaceboDRUGPlacebo
Co-CodamolDRUGCo-Codamol
SB705498DRUG1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersNo
Study Sites5

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...

Countries:ItalySouth KoreaUnited Kingdom
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Frequently asked questions about SB705498

What is SB-705498 used for?

SB-705498 is an investigational small molecule being studied for atopic dermatitis, toothache, acute migraine, and rhinitis. It has been evaluated in clinical trials for acute migraine treatment and for rhinitis, including allergic rhinitis. The drug is in Phase 2 development and remains investigational, not approved.

What does SB-705498 target?

SB-705498 is a small molecule developed by GSK plc. It has been studied in neurology and other therapeutic areas for conditions including migraine and rhinitis. The specific molecular target of SB-705498 is not disclosed in the available clinical trial information.

Who makes SB-705498?

SB-705498 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is an investigational small molecule in Phase 2 clinical development for multiple indications.

What phase is SB-705498 in?

SB-705498 is in Phase 2 clinical development. It has completed six clinical trials, including Phase 1 and Phase 2 studies, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SB-705498 in?

SB-705498 has completed six clinical trials, including NCT00269022 for acute migraine, NCT00731250 and NCT00907933 for rhinitis in healthy volunteers, and NCT01424397 for allergic rhinitis. All trials are completed with no active studies currently enrolling.

Is SB-705498 the same as another drug?

SB-705498 is the primary name used in clinical trials and development records. No alternative names have been reported in the available clinical trial information. The drug is identified solely as SB-705498 across all completed studies.