Phase 2
Completed N=255
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction Pain
Source: ClinicalTrials.gov NCT01062113 ↗Enrolled (actual)
255
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Efficacy Rate (Percentage) of Patient's Impression — 64.1; 25.9 percentage of participants — p=<0.0001
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.
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 |
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. Informational only — not medical advice.