Lidocaine Patch 1.8% for Moderate to Severe Pain From Carpal Tunnel Syndrome

Completed · Phase 4 · Has a placebo group

Conditions studied: Carpal Tunnel Syndrome

In brief

The primary objective is to determine the efficacy of Lidocaine Patch 1.8% in reducing the severity of symptoms in participants with moderate-to-severe pain from Carpal Tunnel Syndrome.

Key facts

Study ID

NCT04245371

Run by

John Papakonstantinou, MD

People needed

45

Starts

2020-02-24

Expected to finish

2023-05-07

Last updated by the study team

2023-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
• Male and female participants, 18 years or older at Screening;
• Participants with Carpal Tunnel Syndrome, confirmed by CT6;
• Pain score of at least 4, based on an 11-point numeric rating scale (NRS) (scale of 0-10), at the screening (baseline) visit;
• Able and willing to provide a written informed consent;
• Able and willing to follow study instructions;
• Able and willing to return to clinic for follow-up visits;
• Able and willing to complete a daily diary;
• Intact skin over the affected wrist;
• Woman of childbearing age agreeing to use 2 forms of contraception.

You may not qualify if…

• Participants presenting with any of the following exclusion criteria will not be enrolled into the study
• Participants must NOT have had prior steroid injection for CTS, CTS surgery, or other intervention/injury to the wrist that might interfere with assessments in the previous 30 days;
• Participants must not have pain at other sites that interfere with their ability to report site-specific pain related to the study (bilateral CT is an exclusion);
• Participants must NOT have cognitive or psychological impairment that interferes with the ability to complete study related assessments;
• Participants with mild (NRS less than 4) or no pain (only numbness) at baseline prior to randomization;
• Opioid tolerance (receiving at least 1 week of oral morphine 60 mg/day OR transdermal fentanyl 25 mcg/hour OR oral oxycodone 30 mg/day OR oral hydromorphone 8 mg/day OR an equianalgesic dose of any other opioid);
• History of sensitivity or allergy to lidocaine or ZTLIDO;
• Irritated, abraded, or otherwise non-intact skin over the affected wrist;
• Concurrently taking tocainide, mexiletine, or local anesthetics;
• Participants with history of or at significant risk for methemoglobinemia;
• Participation in another study of investigational drugs or devices within 30 days before screening, or previous participation in a Lidocaine Patch study;
• Known to or suspected of not being able to comply with the study protocol;
• Any clinically significant condition that would, in the investigator's opinion, preclude study participation for instance alcohol, medication or drug dependency, neurotic personality, psychiatric illness, epilepsy or suicide risk;
• Pregnancy or nursing mother;
• Woman in childbearing age without satisfactory contraception;
• Presence of possible other cause/s for hand pain (i.e., radicular pain, arthritis, injury, surgery) that could confound assessment or self-evaluation of the pain due to Carpal Tunnel Syndrome;
• Participants using topically applied analgesic compounds on the affected area;

Where it is running

• Michigan Orthopaedic & Spine Surgeons — Rochester Hills, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.