Phase 4
N=401
Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy
Post-surgical Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT01075243 ↗Enrolled (actual)
401
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) — 16.08; 12.42; 4.63 Score on a scale — p=0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paracetamol 1000 mg (Drug); Paracetamol 650 mg (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) |
16.08; 12.42; 4.63 | 0.0009 sig |
| SECONDARY Time to Confirmed First Perceptible Relief |
54.72; 69.67; 225.70 | — |
| SECONDARY Time to Onset of Meaningful Pain Relief |
70.53; 88.16; 247.14 | — |
| SECONDARY Time to Start Using Rescue Medication |
360.00; 314.00; 131.00 | — |
| SECONDARY Percentage of Participants Who Took Rescue Medication at 2 Hours |
0.00; 0.00; 1.30 | — |
| SECONDARY Percentage of Participants Who Took Rescue Medication at 6 Hours |
44.20; 51.90; 70.00 | — |
| SECONDARY SPRID at 2 Hours |
6.49; 5.57; 1.55 | — |
| SECONDARY SPRID at 4 Hours |
12.09; 9.45; 3.00 | — |
| SECONDARY Total Pain Relief Score (TOTPAR) at 2 Hours |
4.31; 3.80; 1.36 | — |
| SECONDARY TOTPAR at 4 Hours |
8.21; 6.64; 2.79 | — |
| SECONDARY TOTPAR at 6 Hours |
11.06; 8.83; 4.29 | — |
| SECONDARY Sum of Pain Intensity Difference (SPID) Scores at 2 Hours |
2.17; 1.77; 0.19 | — |
| SECONDARY SPID Scores at 4 Hours |
3.88; 2.81; 0.20 | — |
| SECONDARY SPID Scores at 6 Hours |
5.02; 3.59; 0.34 | — |
| SECONDARY Participants Global Assessment to Response to Treatment (PGART) |
2.20; 1.80; 0.80 | — |
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
Data sourced from ClinicalTrials.gov (NCT01075243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.