Last updated: 11/04/2018 06:06:41
Dental Pain (Following Third Molar Tooth Extraction) Study
GSK study ID
CXA30001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Pivotal Phase III, Single Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Investigate the Efficacy and Safety of Single Oral Doses of 10mg, 25mg, 50mg and 70mg GW406381 and 550mg Naproxen Sodium in Subjects with Pain Following Third Molar Tooth Extraction
Trial description: The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW406381
Enrollment:
300
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dental Pain, Surgery, Dental
Product
GW406381
Collaborators
Not applicable
Study date(s)
December 2004 to April 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
no
- Scheduled for outpatient surgical removal of at least two third molar teeth.
- Subjects who do not achieve moderate to severe pain.
- Subjects who do not use acceptable contraception.
Inclusion and exclusion criteria
Inclusion criteria:
- Scheduled for outpatient surgical removal of at least two third molar teeth.
Exclusion criteria:
- Subjects who do not achieve moderate to severe pain.
- Subjects who do not use acceptable contraception.
- Additional medical criteria will be assessed by the investigator.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-20-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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