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Anti-inflammatory

HT-6184 Treatment Arm for Pain

Phase 2

Recruiting

Research Sponsored by Halia Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The candidate, for any reason, requires surgical extraction of two or more third molars of which at least one is partially or fully impacted in mandibular bone

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 hours post surgery

Awards & highlights

Study Summary

This trial aims to see if a medication called HT-6184 can reduce inflammation and pain in patients after getting their wisdom teeth removed. Participants will take either HT-6184 or a placebo, have

Who is the study for?

This trial is for adults over 18 needing at least one impacted wisdom tooth removed. They must understand the study, consent to it, and follow procedures like blood draws. Women who can have children need a negative pregnancy test and agree to use contraception for a week after their last dose of the study drug.Check my eligibility

What is being tested?

The trial tests HT-6184's effectiveness in reducing inflammation and pain post-wisdom tooth extraction compared to a placebo. Participants will take one oral dose of either HT-6184 or placebo, undergo surgery, rate their pain, attend follow-ups, and make a phone call check-in.See study design

What are the potential side effects?

Specific side effects of HT-6184 are not listed but may include typical reactions related to oral medications such as stomach upset or allergic responses. Pain and discomfort from molar extraction are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery to remove two or more wisdom teeth, with at least one impacted in my jaw.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 hours post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 54 hours post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 hours post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in serum C-reactive protein levels from pre-dose

Incidence of adverse events

Incidence of serious adverse events

Secondary outcome measures

Area under the categorical pain intensity-by-time curve (AUCs)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: HT-6184 Treatment ArmActive Control1 Intervention

Group II: HT-6184 PlaceboPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Halia Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

64 Total Patients Enrolled

Halia Study DirectorStudy DirectorHalia Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this research project?

"Indeed, clinicaltrials.gov shows that this research is currently seeking eligible participants. Originally shared on February 1st, 2024 and last modified on February 16th, 2024, the investigation aims to enroll 80 individuals at a single designated site."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"Affirmative. The information on clinicaltrials.gov confirms the ongoing recruitment for this research investigation, initially posted on February 1st, 2024 and most recently updated on February 16th, 2024. Enrollment of 80 participants is sought at a singular designated location."

Answered by AI

What are the safety considerations for patients receiving treatment with HT-6184 in a clinical trial?

"Our team's assessment at Power rates the safety of the HT-6184 Treatment Arm as a 2, reflecting that while there is some safety data available due to being in Phase 2 stage, no efficacy data has been established yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction

2024. "Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06241742.