Phase 4
N=300
Post-operative Dental Pain Study Comparing Analgesic Efficacy
Post-surgical Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT01082081 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) — 10.60; 5.87; 3.35 Units on a scale — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paracetamol 1000 mg (Drug); Paracetamol 500 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) |
10.60; 5.87; 3.35 | 0.0004 sig |
| SECONDARY Time to Confirmed First Perceptible Pain Relief |
80.63; 119.10; 189.53 | — |
| SECONDARY Time to Onset of Meaningful Pain Relief |
96.44; 129.75; 207.67 | — |
| SECONDARY Time to Start Using Rescue Medication |
242.00; 189.00; 148.00 | — |
| SECONDARY Percentage of Participants Who Took Rescue Medication Within 2 Hours |
5.00; 11.80; 18.30 | — |
| SECONDARY Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours |
57.9; 55.5; 53.3 | — |
| SECONDARY SPRID at 2 Hours |
4.62; 3.26; 1.49 | — |
| SECONDARY SPRID at 4 Hours |
7.82; 4.42; 2.07 | — |
| SECONDARY Total Pain Relief (TOTPAR) at 2 Hours |
3.33; 2.46; 1.47 | — |
| SECONDARY TOTPAR at 4 Hours |
5.82; 3.73; 2.55 | — |
| SECONDARY TOTPAR at 6 Hours |
8.05; 5.18; 4.10 | — |
| SECONDARY Sum of Pain Intensity Difference (SPID) Scores at 2 Hours |
1.3; 0.8; 0.0 | — |
| SECONDARY SPID Scores at 4 Hours |
2.0; 0.7; -0.5 | — |
| SECONDARY SPID Scores at 6 Hours |
2.6; 0.7; -0.8 | — |
| SECONDARY Participants Global Assessment to Response to Treatment (PGART) |
1.54; 1.24; 0.63 | — |
Summary
GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . 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 16 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 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.
Data sourced from ClinicalTrials.gov (NCT01082081). 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.