Health TrialsbyHealthPanel

A Study of LY4515100 in Participants With Pain Following Third Molar Removal

ConditionsAcute PainMolarMolar, ThirdSurgery, Oral
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorEli Lilly and Company

About this trial

The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain after removing impacted third molars. For each participant, the study may last approximately 6 weeks and will include a stay in a Clinical Research Unit (CRU) after third molar removal.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive.

Participant requires extraction of 2 or more third molars, including 2 mandibular molars with partial or full bony impaction, confirmed by panoramic X-ray.

Disqualifiers

Prior dental surgery within 60 days before screening or history of other surgical procedures that could confound surgery or postoperative procedures.

Diagnosis of chronic pain conditions that could confound postsurgical pain reporting in the opinion of the investigator.

Positive urine drug screen or alcohol test during screening or on the day of surgery.

Evidence or history of any other clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases, in the opinion of the investigator, within the last 5 years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4515100

    Drug

    Administered Orally

  • Placebo

    Drug

    Administered Orally

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: LY4515100Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Self-Reported Pain Intensity

Time frame
Baseline, Up to Day 1

Secondary outcomes

1

Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale

Time frame
Baseline, Up to Day 1
2

Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale

Time frame
Baseline, Up to Day 1
3

Time to Rescue Medications

Time frame
Baseline, Up to Day 1
4

Participants Overall Impression of Pain Relief on a Five-Point Scale

Time frame
Baseline, Up to Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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