Phase 2
Completed N=124
A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal
Source: ClinicalTrials.gov NCT01872910 ↗Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS — -3.8; -47.4; -12.7 mm
Summary
The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS |
-3.8; -47.4; -12.7 | — |
| SECONDARY Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose |
2.2; 8.1; 3.6; 1.1; 1.1; 3.8 | — |
| SECONDARY Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS |
-3.2; -40.5; -8.5; 1.0; -0.6; -3.6 | — |
| SECONDARY Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale |
-0.6; -4.1; -1.2; 0.0; 0.3; -1.0 | — |
| SECONDARY Time to First Use of Rescue Medication |
1.8; NA; 2.9; 1.9; 1.8 | — |
| SECONDARY Part A: Time to Onset of First Perceptible Pain Relief |
0.9; 0.7; 1.0 | — |
| SECONDARY Part A: Time to Onset of Meaningful Pain Relief |
3.8; 1.2; 2.2 | — |
| SECONDARY Part A: Patient Global Impression of Improvement (PGI-I) Scale Score |
2.91; 1.95; 3.12; 2.17; 1.92; 2.45 | — |
Eligibility Criteria
Inclusion Criteria
- Have at least 2 third molars which are clinically indicated for extraction. At least 1 molar should be a mandibular third molar with partial or complete bony impaction
- Are overtly healthy as determined by medical history and limited physical examination
Exclusion Criteria
- Have chronic pain [for example (e.g.), fibromyalgia] or are experiencing episodic pain not related to the wisdom teeth (e.g., migraine pain) that could affect pain measurements as judged by the investigator
- Have temporomandibular joint disease or other condition which could affect pain processing or sensation, affect recovery from dental surgery, or otherwise affect ability to assess pain signal, in the opinion of the investigator
- Have substantial anxiety regarding dental or medical procedures as measured by the Corah Dental Anxiety Scale
- Are currently using or have recently used drugs that may confound assessment of the inflammatory response or pain including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin and other analgesics, antihistamines, steroids, antidepressants, attention-enhancing drugs, or herbal supplements
Data sourced from ClinicalTrials.gov (NCT01872910). 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.