A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Pain Relief
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 401
- Locations
- 1
- Primary Endpoint
- Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Paracetamol 1000mg
Paracetamol 1000mg
Intervention: Paracetamol 1000 mg (Drug)
Paracetamol 650 mg
Paracetamol 650 mg
Intervention: Paracetamol 650 mg (Drug)
Placebo
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
Time Frame: Every two hours from Baseline to 6 hours post dose
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Secondary Outcomes
- Time to Start Using Rescue Medication(Baseline to 6 hours post dose)
- Percentage of Participants Who Took Rescue Medication at 6 Hours(Baseline to 6 hours post dose)
- Percentage of Participants Who Took Rescue Medication at 2 Hours(Baseline to 2 hours post dose)
- SPRID at 2 Hours(Every two hours from baseline to 2 hours post dose)
- SPID Scores at 4 Hours(Every two hours from baseline to 4 hours post dose)
- Time to Confirmed First Perceptible Relief(Baseline to 6 hours post dose)
- Time to Onset of Meaningful Pain Relief(Baseline to 6 hours post dose)
- Sum of Pain Intensity Difference (SPID) Scores at 2 Hours(Every two hours from baseline to 2 hours post dose)
- SPRID at 4 Hours(Every two hours from baseline to 4 hours post dose)
- Total Pain Relief Score (TOTPAR) at 2 Hours(Every two hours from baseline to 2 hours post dose)
- TOTPAR at 4 Hours(Every two hours from baseline to 4 hours post dose)
- SPID Scores at 6 Hours(Every two hours from baseline to 6 hours post dose)
- Participants Global Assessment to Response to Treatment (PGART)(Baseline to 6 hours post dose)
- TOTPAR at 6 Hours(Every two hours from baseline to 6 hours post dose)