Phase 2
N=255
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01062113 ↗Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Efficacy Rate (Percentage) of Patient's Impression — 64.1; 25.9 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Celecoxib (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Rate (Percentage) of Patient's Impression |
64.1; 25.9 | <0.0001 sig |
| SECONDARY Number of Participants in Each Pain Intensity (PI) With 4 Categories |
11; 3; 34; 24; 18; 28 | — |
| SECONDARY Pain Intensity Measured by Visual Analog Scale (VAS) |
35.8; 51.9 | 0.0003 sig |
| SECONDARY Differences in Pain Intensity (PI) Measured by VAS Among Participants |
33.4; 12.3 | <0.0001 sig |
Summary
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.
Eligibility Criteria
Inclusion Criteria
Initial dose:
- 20 to 64 years
- Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting
- Patients with pain that meets both of the following criteria
- Pain intensity (4-categorical): "moderate pain" or "severe pain"
- Pain intensity (VAS): 45.0 mm or more
Additional dose:
- Patients with pain that corresponds to "4. Agree" or "5. Strongly agree" as the answer to the "question about the pain intensity" during the period from 5 hours to 12 hours post-initial dose of the study drug
Exclusion Criteria
- Patients with acute inflammatory findings in the oral cavity necessitating treatment
- Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction
Data sourced from ClinicalTrials.gov (NCT01062113). 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.