Amitriptyline 10% or ketamine 10% cream in neuropatic pain: a randomised doubleblind, placebo-controlled, cross-over multicenter pilot study
Phase 4
Recruiting
- Conditions
- neuropathic pain syndrome10062915
- Registration Number
- NL-OMON47259
- Lead Sponsor
- Westfries Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
- peripheral neuropathic pain (DOT: 130)
- >= 18 years old, competent
- >= 5 and <10 on the Visual Analogue Scale (VAS)
- max. 10% of the bodysurface
Exclusion Criteria
- pregnancy or planned pregnancy during study period
- open wounds on the place of the neuropatic pain
- current use of topical analgetic
- presence of other painsyndromes, like the widespread painsyndrome
- presence of serious psychological or psyciatric morbidity
- addiction on intoxicans
- insufficient control of the Dutch language
- use of ketamine and amitriptyline
- known allergy of the studymedication (active substance en additives)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Difference between active and placebo cream pain score on Numerical Rating<br /><br>Scale</p><br>
- Secondary Outcome Measures
Name Time Method <p>Feasibility of a randomised, doubleblind, placebo-controlled, cross-over study<br /><br>with the folowing questions: effectiveness on the other rating scales,<br /><br>percentage patients responding and will be included after the testing phase;<br /><br>comprehensibility and completeness of questionnaires, percentage drop-outs,<br /><br>side effects, logistics and randomization process, tolerance and safety of the<br /><br>creams<br /><br><br /><br><br /><br>.</p><br>