RecruitingPhase 2ACTRN12617000206325

A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain


Sponsor

RR MedSciences Pty Ltd

Enrollment

22 participants

Start Date

Sep 14, 2017

Study Type

Interventional

Conditions

Summary

This is a double blind, placebo controlled, randomized crossover, pilot study assessing the therapeutic effects of RM191A in participants suffering from neuropathic pain. Each participant receives both treatment (separated by three days of washout period) and randomisation is used to determine the order in which the participant received each treatment. The 10% RM191A spray will be applied four times a day at 8AM, 12PM, 4PM and 8PM with up to eight sprays per area. Changes in intensity of neuropathic pain will be assessed by NPRS.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a topical spray called RM191A for people who have moderate to severe neuropathic pain — nerve pain that feels like burning, shooting, or electric sensations. The spray is applied to the skin four times a day over the painful area. In this small pilot study, participants try both the active spray and a placebo spray at different times, so everyone has a chance to receive the real treatment. You may be eligible if: - You are 18 years old or older - You have moderate to severe neuropathic pain that has been present for at least 3 months - The painful area is suitable for topical treatment (skin is intact) - Your pain medications have been stable for at least 7 days You may NOT be eligible if: - Your pain is mainly from a cause other than nerve damage - You have a skin condition (like eczema or psoriasis) in the treatment area - You changed long-acting pain medications within the last 7 days - You have been using topical pain medications on the area recently - You have a known allergy to copper - You have Wilson's Disease (a condition affecting copper processing) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Single dose, crossover study design whereby each participant receives Copper Amino Acid Chelate (RM191A) complex (10%) in the form of spray on one occasion and Placebo on the other occasion separated

Single dose, crossover study design whereby each participant receives Copper Amino Acid Chelate (RM191A) complex (10%) in the form of spray on one occasion and Placebo on the other occasion separated by three days washout period. The participant will be blinded and randomised and receive treatments in random order. Participants are anticipated to use either the active RM191A or Placebo spray over each of the recorded painful area four times a day at 8AM, 12PM, 4PM and 8PM with up to eight sprays per area for five consecutive days. Upon the completion of first five days of treatment, the participants will crossover to the other arm and start and repeat the other treatment as above for another five days after three days of washout period. Participants will be required to complete Participant Diary at approximately 8 PM every evening following the Screening Visit prior to their 8PM intervention. During each scheduled Clinic Follow Up Visit, these diaries will be monitored to ensure participant's adherence to the intervention as per the study protocol. Participants are required to attend four Clinic Follow Up Visits once they are enrolled into the study and will complete questionnaires on pain, laboratory testings to assess the health of the participants and be monitored for any abnormalities. The investigational product and the placebo comes in 150 mL bottle and each spray will be 0.2 mL in volume.


Locations(1)

Royal North Shore Hospital - St Leonards

NSW, Australia

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ACTRN12617000206325


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