None listed
Conditions
Brief 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.
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 spra
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.
Sponsors
RR MedSciences Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1, Male/female patient aged 18 years or older, with moderate to severe neuropathic pain present for at least 3 months. 2. Affected area is appropriate for topical treatment. 3. Skin is intact over the area to be treated. 4. Pain must be due to neuropathic pain that, in the opinion of the Investigator, is of an appropriate severity for treatment. 5. Patient must have appropriate NPRS "average pain over the last 24 hours" for at least 3 of the 7 days prior to the Baseline Visit. 6. Prior pain medications expected to be continued at current level for the duration of the study.
Exclusion criteria
1. Significant pain due to causes other than neuropathic pain. 2. Any history of a dermatological condition or recurrent generalized skin disorder in the area to be treated within last 5 years, inclduing psoriasis, eczema or any other skin condition that might interfere with study assessments. 3. Change in dose of long acting opioids or adjuvant analgesic medications within 7 days of the screening visit, during the screening period prior to baseline assessment of pain and/or during the study. 4. Current or recent use of any topically applied non-opioid pain medications on the painful areas within 3 days prior to Baseline assessment of pain and during the study. 5. Known allergy to copper. 6. Known diagnosis of WIlson's Disease.
Outcome results
None listed