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SB-705498 Dental Pain Study

This study is currently recruiting patients

Verified by GlaxoSmithKline September 2006

Sponsored by: GlaxoSmithKline
Information provided by: Glaxo Smith Kline
ClinicalTrials.gov Identifier: NCT00281684


Purpose

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


Condition Intervention Phase
Dental Pain Drug: SB-705498
Phase I

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:  140

Study start: December 2005

Eligibility

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00281684


United Kingdom
GSK Clinical Trials Call Center, London,  SW17 0RE,  United Kingdom; Recruiting
GSK Clinical Trials Call Center  1-877-379-3718    j.taubel@richmondpharmacology.com 

Study chairs or principal investigators

GSK Clinical Trial, B.Sc.,  Study Director,  GlaxoSmithKline   

More Information

Study ID Numbers:  VRA105345
Last Updated:  September 26, 2006
Record first received:  January 23, 2006
ClinicalTrials.gov Identifier:  NCT00281684
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2006-09-29





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