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NCT06391125 · ClinicalTrials.gov registry record · Phase 3
LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment
A Phase 3 study of Syphilis Infection and Benzathine Penicillin Adverse Reaction, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT06391125: Recruiting Phase 3 study of Syphilis Infection and Benzathine Penicillin Adverse Reaction, sponsored by Washington University School of Medicine.
NCT06391125 is a Phase 3 study of Syphilis Infection and Benzathine Penicillin Adverse Reaction that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06391125, a Phase 3 study of Syphilis Infection and Benzathine Penicillin Adverse Reaction, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G (BPG) or Bicillin, used to treat syphilis infections. A study published in the Journal of Family Practice in 2001 compared the pain experienced during bicillin injections with and without the use of lidocaine. The study found that patients who received lidocaine injections before receiving bicillin reported significantly less pain compared to those who received bicillin injections without lidocaine. Per the International Union against Sexually Transmitted Infections (IUSTI) European Guidelines for syphilis management, lidocaine has been used as a diluent for BPG since 1998. In the United States (US), BPG often comes prepackaged and lidocaine is unable to be used as a diluent with the same ease as it is in Europe. In light of this, the investigators propose a randomized controlled trial of benzathine penicillin G with and without lidocaine to quantify any site pain reduction with lidocaine in patients being treated for syphilis. This study is a randomized, double blinded, placebo controlled trial. During this study, patients needing BPG treatment for syphilis will be screened for any penicillin allergies and consented to their participation. Each participant will receive 2 injections of BPG, 1.2 million units each (2x1.2 million units = 2.4 million units, the standard dose for syphilis treatment), as intramuscular injections, one in each gluteal muscle, with one of the injections randomly having 0.5ml of 1% lidocaine added while the other has 0.5 ml normal saline solution. The side of each injection will be randomized by the medical assistant (MA)/nurse filling the vials and the injecting MA will be blinded, as well as the study participant, as to which vial contains lidocaine and which contains normal saline. The participants will then be asked to rate their pain from 0-10 on each site of injection at 10 minutes post injection, th
Primary Outcome
The average rating of participants' injection site pain with added lidocaine from 0 (no pain) to 10 (extreme pain) at 10 minutes post injection
Conditions Studied
Interventions
- DRUG Lidocaine
- DRUG normal Saline
Study Locations (1)
Missouri
- WashU Infectious Diseases Clinic - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
What NCT06391125 shows while recruiting
NCT06391125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Syphilis Infection appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine is the first listed.
NCT06391125 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06391125 about?
NCT06391125 is a clinical study titled "LIMIT Trial - Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema Pallidum Treatment". There is evidence to suggest that lidocaine can help reduce the pain associated with intramuscular injections of benzathine penicillin G (BPG) or Bicillin, used to treat syphilis infections. A study published in the Journal of Family Practice in 2001 compared the pain experienced during bicillin inj...
What is the current status of trial NCT06391125?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2024-07-01. Estimated completion is 2025-12.
What conditions does trial NCT06391125 study?
This clinical trial studies the following conditions: Syphilis Infection, Benzathine Penicillin Adverse Reaction.
What interventions are being tested in trial NCT06391125?
The interventions under investigation include: Lidocaine (DRUG), normal Saline (DRUG).
Who is sponsoring clinical trial NCT06391125?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06391125 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06391125's enrollment target sits among peer trials
48 1863rd of 2000 higher than 134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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