A Study of LY4515100 in Participants With Pain Following Third Molar Removal
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LY4515100, Placebo.
- Who it may be relevant to
- Registry conditions: Acute Pain, Molar, Molar, Third, Surgery, Oral. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Oral Dose of LY4515100, in Participants Experiencing Moderate-to-Severe Acute Pain Following Surgical Removal of Impacted Third Molars
Overview
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.
Interventions
- Drug LY4515100
Administered Orally - Drug Placebo
Administered Orally
Primary outcome measures
- Change from Baseline in Self-Reported Pain Intensity [Time frame: Baseline, Up to Day 1]
Secondary outcome measures (5)
- Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale [Time frame: Baseline, Up to Day 1]
- Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale [Time frame: Baseline, Up to Day 1]
- Time to Rescue Medications [Time frame: Baseline, Up to Day 1]
- Participants Overall Impression of Pain Relief on a Five-Point Scale [Time frame: Baseline, Up to Day 1]
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100 [Time frame: Baseline, Up to Day 1]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- History of malignancy of any organ system treated or untreated, within 5 years prior to consent. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell carcinoma of the skin, or localized squamous carcinoma of the skin if the participant has been treated and is considered cured.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- JBR Clinical Research — Salt Lake City
Identifiers
NCT: NCT07511816 · 27815 · J6V-MC-OIAF