Last updated: 11/04/2018 04:21:49
Post-operative dental pain study comparing two different dosage of analgesic efficacy
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to compare the analgesic efficacy of two different paracetamol doses as measured by post-operative pain relief
Trial description: GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Sum of Pain Relief and Pain Intensity Differences from 0 to 6 hours (SPRID 6 hours)
Timeframe: Every two hours from Baseline to 6 hours post dose
Secondary outcomes:
Time to confirmed first perceptible relief
Timeframe: Baseline to 6 hours post dose
Time to onset of meaningful pain relief
Timeframe: Baseline to 6 hours post dose
Time to start using rescue medication
Timeframe: Baseline to 6 hours post dose
Percentage of participants who took rescue medication at 2 hours
Timeframe: Baseline to 2 hours post dose
Percentage of participants who took rescue medication at 6 hours
Timeframe: Baseline to 6 hours post dose
SPRID at 2 hours
Timeframe: Every two hours from baseline to 2 hours post dose
SPRID at 4 hours
Timeframe: Every two hours from baseline to 4 hours post dose
Total pain relief score (TOTPAR) at 2 hours
Timeframe: Every two hours from baseline to 2 hours post dose
TOTPAR at 4 hours
Timeframe: Every two hours from baseline to 4 hours post dose
TOTPAR at 6 hours
Timeframe: Every two hours from baseline to 6 hours post dose
Sum of Pain intensity difference (SPID) scores at 2 hours
Timeframe: Every two hours from baseline to 2 hours post dose
SPID scores at 4 hours
Timeframe: Every two hours from baseline to 4 hours post dose
SPID scores at 6 hours
Timeframe: Every two hours from baseline to 6 hours post dose
Participants Global Assessment to response to treatment (PGART)
Timeframe: Baseline to 6 hours post dose
Interventions:
Enrollment:
401
Primary completion date:
2010-31-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Post-surgical dental pain
Product
paracetamol
Collaborators
Not applicable
Study date(s)
November 2009 to March 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
No
- Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon’s discretion, regardless of impaction level.
- Pregnant and lactating females
- Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon’s discretion, regardless of impaction level.
Exclusion criteria:
- Pregnant and lactating females
- Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery
- Current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-31-03
Actual study completion date
2010-31-03
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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