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LY3023703

Phase 2

Acute Pain | Small molecule | Pain |Eli Lilly and Company|Trials Updated: Sep 23, 2019

LY3023703 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Jul 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

LY3023703 clinical trials

LY3023703 · 1 trial · 1 indication

Phase 2 1
NCT01872910A Study of LY3023703 Testing Pain Relief After Wisdom Teeth RemovalAcute Pain
COMPLETED124 Analytics
PHASE2COMPLETED
A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal
Acute PainUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS
0 to 8 h post-dose

Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: \[the area under the change in pain intensity versus time curve\] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.

Secondary Endpoints

Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose
0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS
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
Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale
0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPart 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.
30 milligrams (mg) LY3023703EXPERIMENTALPart 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.
400 mg CelecoxibACTIVE_COMPARATORPart 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.

Interventions

NameTypeDescription
PlaceboDRUGAdministered orally
LY3023703DRUGAdministered orally
CelecoxibDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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: ...

Countries:United States
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Competitive Landscape -Acute Kidney Injury 13 trials (matched to "Acute Pain")

Top 1 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2AZD4144
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Frequently asked questions about LY3023703

What is LY3023703?

LY3023703 is an investigational small molecule developed by Eli Lilly and Company for the treatment of acute pain. It was studied in a Phase 2 clinical trial involving 124 participants. It is not described as an approved medicine and remains an investigational agent in clinical development.

What is LY3023703 used for?

LY3023703 was developed for the treatment of acute pain. Its only recorded clinical study evaluated pain relief after wisdom teeth removal, a standard acute pain model. The trial enrolled 124 participants in the United States and has been completed.

Who makes LY3023703?

LY3023703 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program studying this small molecule for acute pain.

What phase is LY3023703 in?

LY3023703 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program enrolled 124 participants in a randomized, double-blind, placebo-controlled study for acute pain.

What clinical trials is LY3023703 in?

LY3023703 has been studied in one clinical trial, NCT01872910, titled A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal. It was a completed Phase 2 trial with 124 participants, randomized, double-blind, and placebo-controlled, conducted in the United States.

What type of drug is LY3023703?

LY3023703 is a small molecule drug candidate. It was evaluated in a Phase 2 randomized, double-blind, placebo-controlled trial for acute pain, with enrollment of 124 participants. The study has been completed and no active trials are ongoing.