A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal

Lilly

Status and phase: Completed; Phase 2

Conditions: Acute Pain

Treatments: Drug: Placebo; Drug: LY3023703; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872910

I6H-MC-MCBC (Other Identifier)

14852

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Part A: Single oral administration of placebo matching corresponding LY3023703 dose administered orally once as a capsule post dental surgery. Part B: Single oral administration of placebo matching corresponding LY3023703 administered orally once as a capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period.

Treatment:

Drug: Placebo

30 milligrams (mg) LY3023703

Experimental group

Description:

Part A: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-milligrams (mg) capsule post dental surgery. Part B: Single oral administration of 30 milligrams (mg) LY3023703 administered orally once as a 30-mg capsule, post dental surgery and post dialysate probe placement. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period.

Treatment:

Drug: LY3023703

400 mg Celecoxib

Active Comparator group

Description:

Part A: Single oral administration of 400 mg celecoxib (Positive control) administered orally once as two 200-mg capsules post dental surgery (Positive control). Participants received two 200-mg celecoxib capsules during Pre-Part B.The purpose of Pre-Part B was to develop proficiency in the dialysate placement, collection, and maintenance techniques before moving to Part B. Celecoxib was not administered in Part B. Part B of this study assessed whether LY3023703 selectively inhibited the prostaglandin E(PGE) surge in the wound dialysate during the postoperative period.

Treatment:

Drug: Celecoxib