ACTRN12617000206325
Recruiting
Phase 2
A double blind, placebo controlled, randomized crossover, pilot study of topical RM191A spray for the relief of neuropathic pain
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- RR MedSciences Pty Ltd
- Enrollment
- 22
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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