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Amitriptyline 10% or ketamine 10% cream in neuropatic pain: a randomised doubleblind, placebo-controlled, cross-over multicenter pilot study

Amitriptyline 10% or ketamine 10% cream in neuropatic pain: a randomised doubleblind, placebo-controlled, cross-over multicenter pilot study - Pilot study amitriptyline or ketaminecreme in neuropatic pain.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47259
Enrollment
80
Registered
2019-03-21
Start date
2017-02-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropathic pain syndrome

Interventions

local treatment with either ketamine 10% or amitriptyline 10% cream or placebo
neuropathic
pain-relievingcream
Pilot-study

Sponsors

Westfries Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - peripheral neuropathic pain (DOT: 130) - >= 18 years old, competent - >= 5 and

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Difference between active and placebo cream pain score on Numerical Rating Scale

Secondary

MeasureTime frame
Feasibility of a randomised, doubleblind, placebo-controlled, cross-over study with the folowing questions: effectiveness on the other rating scales, percentage patients responding and will be included after the testing phase; comprehensibility and completeness of questionnaires, percentage drop-outs, side effects, logistics and randomization process, tolerance and safety of the creams .

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)