SB-705498 Dental Pain Study
This study is currently recruiting patients
Verified by GlaxoSmithKline September 2006
|Information provided by:
||Glaxo Smith Kline
This clinical trial is a two-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
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: 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
Further study details as provided by GlaxoSmithKline:
Primary Outcomes: Analgesic efficacy of SB-705498 following dental surgery.
Secondary Outcomes: Safety and tolerability of SB-705498.
Expected Total Enrollment:
Study start: December 2005
Ages Eligible for Study:
Genders Eligible for Study:
- Subject is scheduled for outpatient surgical removal of up to four third molar teeth under local anesthesia.
- At least one third molar tooth must be a fully or partially impacted in the mandible requiring bone removal.
- Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment (up to 24 hrs post dose).
- Ability to read, comprehend, and record information required by protocol.
- Subject is willing and able to provide signed and dated written informed consent prior to study participation.
- Subject has a history or presence of significant organ disease or mental illness.
- Subject has been exposed to analgesics other than aspirin (including prescription and over the counter NSAIDs or COX-2 inhibitors)
within 24 hours prior to the start of surgery.
- Subject is unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g . benzodiazepines)
within 24 hours prior to the start of surgery and for the duration of their participation in the study.
- Following screening (and 24 h Holter ECG) the subject has a significant abnormality that, in the opinion of the investigator
makes them unsuitable for the study.
- Subject is judged by the investigator not to be a suitable candidate for ibuprofen or co-codamol therapy based on medical
history, concomitant medications, and concurrent systemic disease as described in the product labeling, e.g., peptic ulcer
disease, angioedema, bronchospastic reactivity (e.g., asthma), rhinitis and nasal polyps induced by aspirin or other NSAIDs.
Please refer to this study by ClinicalTrials.gov identifier
GSK Clinical Trials Call Center, London,
United Kingdom; Recruiting
Study chairs or principal investigators
GSK Clinical Trial, B.Sc., Study Director, GlaxoSmithKline
Study ID Numbers:
September 26, 2006
Record first received:
January 23, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2006-09-29