Recruitment

Recruitment Status
Completed
Estimated Enrollment
130

Inclusion Criterias

Are overtly healthy as determined by medical history and limited physical examination
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
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

Exclusion Criterias

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
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 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
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

Summary

Conditions
Acute Pain
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 45 years
Gender
Both males and females

Inclusion Criterias

Are overtly healthy as determined by medical history and limited physical examination
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
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

Exclusion Criterias

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
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 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
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

Locations

Austin, Texas, 78705
Austin, Texas, 78705

Tracking Information

NCT #
NCT01872910
Collaborators
Not Provided
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company