A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain
RR MedSciences Pty Ltd
22 participants
Sep 14, 2017
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
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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 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)
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ACTRN12617000206325