250 Participants Needed

LTG-001 for Acute Pain

Do
Overseen ByDirector of Clinical Operations
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it excludes those who use NSAIDs, benzodiazepines, opioids, or medications that affect heart rhythms. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are:Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours?Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain.Participants will:Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up.Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain

Eligibility Criteria

Adults who've had their impacted third molars (wisdom teeth) surgically removed and are experiencing acute pain can participate. Specific details about eligibility criteria are not provided, but typically participants must be in good health aside from the condition being studied.

Inclusion Criteria

My post-surgery pain fits the study's criteria.
Subject must agree to study required use of birth control
I need to have 2 or more wisdom teeth removed, including at least 2 lower ones that are partially or fully covered by bone.
See 1 more

Exclusion Criteria

I cannot take medications by mouth.
I have sleep apnea or use a CPAP machine at home.
I haven't had dental or other surgeries in the last 60 days.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take LTG-001 one time after the surgical removal of impacted third molars and remain at the clinic for 12 hours for monitoring

12 hours
1 visit (in-person)

Follow-up

Participants return after a week for a safety check-up

1 week
1 visit (in-person)

Treatment Details

Interventions

  • LTG-001
Trial Overview The trial is testing LTG-001's effectiveness in treating post-surgical pain after wisdom tooth removal. It involves a single dose of LTG-001 at various strengths or a placebo, with patients monitored for 12 hours post-dosing and returning after a week for safety evaluation.
Participant Groups
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LTG-001 Mid DoseExperimental Treatment1 Intervention
Group II: LTG-001 Low DoseExperimental Treatment1 Intervention
Group III: LTG-001 High DoseExperimental Treatment1 Intervention
Group IV: SuzetrigineActive Control1 Intervention
Group V: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Latigo Biotherapeutics

Lead Sponsor

Trials
4
Recruited
480+
Unbiased ResultsWe believe in providing patients with all the options.
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