RecruitingPhase 2ACTRN12615000310561

Systemic vs. topical Reparil 'Registered Trademark' for the treatment of Temporomandibular Joint and Masticatory Muscle Pain

The effectiveness of using systemic oral tablet Reparil 'Registered Trademark' vs. topical gel of Reparil 'Registered Trademark' compared to placebo in the treatment of temporomandibular joint (TMJ), masticatory muscle pain, mandibular function and Tolerability to treatment.


Sponsor

Hawler Medical University

Enrollment

50 participants

Start Date

Dec 1, 2014

Study Type

Interventional

Conditions

Summary

To compare the effectiveness of using systemic oral tablet Reparil 'Registered Trademark' vs. topical gel of Reparil 'Registered Trademark' compared to placebo in the treatment of temporomandibular joint (TMJ), masticatory muscle pain, mandibular function and Tolerability to treatment.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two forms of a medication called Reparil — one taken as a tablet and one applied as a gel — for treating pain in the jaw joint (temporomandibular joint or TMJ) and the muscles used for chewing. A placebo (dummy treatment) group is also included for comparison. The goal is to find out which form of Reparil works better and is better tolerated. You may be eligible if: - You are between 18 and 65 years old - You have self-reported facial ache or pain in the jaw muscles, jaw joint, or in front of the ear - You have a clinical diagnosis of a temporomandibular disorder (TMD) based on research diagnostic criteria - Your jaw joint pain has been present for at least 1 month on most days You may NOT be eligible if: - You have infectious arthritis, crystal-induced arthropathy, or another musculoskeletal disorder - You have a primary diagnosis of myofascial pain - Your headaches are primarily due to migraine or another specific head pain condition - You have an active infection in your teeth, ears, eyes, nose, or throat - You have untreated depression or unstable antidepressant medication - You have dental disease requiring ongoing treatment - You are pregnant or breastfeeding - You are sensitive to any ingredient in Reparil Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Reparil dragees COMPOSITION: Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:2 dragees (oral administration) Duration 3 times daily Mode of administration: oral drag Method

Reparil dragees COMPOSITION: Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:2 dragees (oral administration) Duration 3 times daily Mode of administration: oral drag Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 3 months Reparil-gel N COMPOSITION: 100 g contains Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:Spread a thin layer of the gel onto the skin of the affected area Duration 3 times daily Mode of administration:Topical Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 3 months


Locations(1)

Iraq

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ACTRN12615000310561