Clinical trial NCT01872910: A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal
Official title: Evaluation of the Acute Analgesic Efficacy of a Single Dose of LY3023703 in Patients With Postsurgical Dental Pain: A Parallel, Double-Blind, Randomized, Placebo and Positive Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Keywords: Wisdom tooth extraction
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS
timeFrame: 0 to 8 h post-dose
Secondary outcomes:
measure: Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose
timeFrame: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
measure: Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS
timeFrame: Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose
measure: Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale
timeFrame: 0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
measure: Time to First Use of Rescue Medication
timeFrame: Study drug administration to first use of rescue medication (0 to 24 h post-dose)
measure: Part A: Time to Onset of First Perceptible Pain Relief
timeFrame: Study drug administration to first perceptible pain relief (0 to 24 h post-dose)
measure: Part A: Time to Onset of Meaningful Pain Relief
timeFrame: Study drug administration to meaningful pain relief (0 to 24 h post-dose)
measure: Part A: Patient Global Impression of Improvement (PGI-I) Scale Score
timeFrame: 2, 4, 8, 12 and 24 h post-dose
Other outcomes:
Locations:
city: Austin
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: