A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

30 milligrams (mg) LY3023703

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.

Group Type EXPERIMENTAL

LY3023703

Intervention Type DRUG

Administered orally

400 mg Celecoxib

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.

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Administered orally

Interventions

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Placebo

Administered orally

Intervention Type DRUG

LY3023703

Administered orally

Intervention Type DRUG

Celecoxib

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY3023703 phosphate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes