Clinical trial NCT01075243: Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
Official title: A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-surgical Dental Pain
Keywords: dental pain
paracetamol
Post-surgical dental pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: 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:
measure: Time to Confirmed First Perceptible Relief
timeFrame: Baseline to 6 hours post dose
measure: Time to Onset of Meaningful Pain Relief
timeFrame: Baseline to 6 hours post dose
measure: Time to Start Using Rescue Medication
timeFrame: Baseline to 6 hours post dose
measure: Percentage of Participants Who Took Rescue Medication at 2 Hours
timeFrame: Baseline to 2 hours post dose
measure: Percentage of Participants Who Took Rescue Medication at 6 Hours
timeFrame: Baseline to 6 hours post dose
measure: SPRID at 2 Hours
timeFrame: Every two hours from baseline to 2 hours post dose
measure: SPRID at 4 Hours
timeFrame: Every two hours from baseline to 4 hours post dose
measure: Total Pain Relief Score (TOTPAR) at 2 Hours
timeFrame: Every two hours from baseline to 2 hours post dose
measure: TOTPAR at 4 Hours
timeFrame: Every two hours from baseline to 4 hours post dose
measure: TOTPAR at 6 Hours
timeFrame: Every two hours from baseline to 6 hours post dose
measure: Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
timeFrame: Every two hours from baseline to 2 hours post dose
measure: SPID Scores at 4 Hours
timeFrame: Every two hours from baseline to 4 hours post dose
measure: SPID Scores at 6 Hours
timeFrame: Every two hours from baseline to 6 hours post dose
measure: Participants Global Assessment to Response to Treatment (PGART)
timeFrame: Baseline to 6 hours post dose
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22.