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Trial registered on ANZCTR


Registration number
ACTRN12617000206325
Ethics application status
Approved
Date submitted
6/02/2017
Date registered
8/02/2017
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain
Scientific title
A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain
Secondary ID [1] 291090 0
NIL
Universal Trial Number (UTN)
Trial acronym
RRM-CIP-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic Pain 301898 0
Condition category
Condition code
Neurological 301567 301567 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297076 0
Treatment: Drugs
Comparator / control treatment
Placebo is matched to the investigational RM191A in terms of odour and visual appearances, but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 300976 0
Change in Patient-Reported Neuropathic Pain Intensity as assessed by Numeric Pain Rating Scale (NPRS)
Timepoint [1] 300976 0
Baseline, Day 1, Day 3, Day 8 (End of Washout), Day 9, Day 11
Secondary outcome [1] 331312 0
To assess the safety and tolerability of topical RM191A spray by careful monitoring of following safety parameters: 1. Skin irritation 2. Adverse events 3. Evaluation of any medically significant changes, based on neurological and physical examination findings 4. Clinical laboratory testing with abnormal results
Timepoint [1] 331312 0
Baseline, Day 3, Day 5, Day 9, Day 11, Day 13, Day 17 (End of Study Visit)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be identified by screening number. The screening number will be issued once the participant has given written consent to participate in the study. Once the participant is deemed eligible and enrolled into the study, they will be randomly allocated into placebo first and treatment first groups. The primary investigator, study team and the participants will be unaware of which treatment they would receive first. The order of allocation will be determined by sealed opaque envelope that will contain the order of kit serial number that they will receive.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced two-way crossover design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7440 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 15252 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 295528 0
Commercial sector/Industry
Name [1] 295528 0
RR MedSciences Pty Ltd
Address [1] 295528 0
Suite 1a, Level 2
802 Pacific Highway
Gordon, NSW, Australia
Country [1] 295528 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RR MedSciences Pty Ltd
Address
Suite 1a, Level 2
802 Pacific Highway
Gordon, NSW, Australia
Country
Australia
Secondary sponsor category [1] 294345 0
None
Name [1] 294345 0
Address [1] 294345 0
Country [1] 294345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296850 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 296850 0
Ethics committee country [1] 296850 0
Australia
Date submitted for ethics approval [1] 296850 0
28/11/2016
Approval date [1] 296850 0
01/03/2017
Ethics approval number [1] 296850 0
HREC/16/HAWKE/483

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72222 0
Prof Paul Glare
Address 72222 0
Pain Management Research Institute
Royal North Shore Hospital
Level 2, Douglas Building
Reserve Road
St Leonards, NSW, 2065
Country 72222 0
Australia
Phone 72222 0
+61 2 9463 1562
Fax 72222 0
Email 72222 0
paul.glare@sydney.edu.au
Contact person for public queries
Name 72223 0
Mr Llewellyn Casbolt
Address 72223 0
RR MedSciences Pty Ltd
Suite 1a, Level 2
802 Pacific Highway
Gordon, NSW, 2072
Country 72223 0
Australia
Phone 72223 0
+61 412 282 101
Fax 72223 0
Email 72223 0
llewellyn@rrmedsciences.com
Contact person for scientific queries
Name 72224 0
Mr Llewellyn Casbolt
Address 72224 0
RR MedSciences Pty Ltd
Suite 1a, Level 2
802 Pacific Highway
Gordon, NSW, 2072
Country 72224 0
Australia
Phone 72224 0
+61 412 282 101
Fax 72224 0
Email 72224 0
llewellyn@rrmedsciences.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results