Pilot-study with Amitriptyline 10% and Ketamine10% creme in neuropatic pain.

Amitriptyline 10% and ketamine 10% cream in neuropathic pain: A randomised, double-blind, placebo-controlled cross-over pilot study with a three months open follow-up - Randomised study evaluating the treatment neuropatic pain with cream

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005656-26-NL

Enrollment

Registered

2015-11-19

Start date

2015-10-14

Completion date

Unknown

Last updated

2015-12-07

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

Conditions

Patients with peripheral neuropathic pain or scar pain MedDRA version: 17.1 Level: PT Classification code 10049002 Term: Scar pain System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1 Level: LLT Classification code 10029181 Term: Nerve pain System Organ Class: 100000004852

Interventions

Product Name: Ketamine Product Code: 1867-66-9 Pharmaceutical Form: Cream INN or Proposed INN: Ketamine.HCl CAS Number: 1867-66-9 Other descriptive name: KETAMINE HYDROCHLORIDE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - peripheral neuropatic pain (DOT: 130) - =18 year, competent - =5 en =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - pregnancy of planned pregnancy during studiyperiod - open wounds at the same spot of the neuropatic pain - current use of topic analgetic - presence of other pains yndromes, such as the wide spread pain syndrome - presence of serious psychological or psychiatric morbidity - addiction to intoxicants - insuffient control of the Dutch language - hypersensitivity of the medication - use of ketamine and amitriptyline

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT;Secondary Objective: none;Primary end point(s): Difference between active and placebo cream pain score on Numeric Rating Scale;Timepoint(s) of evaluation of this end point: End of studyperiod	—

Secondary

Measure	Time frame
Secondary end point(s): Feasibility of a randomised, doubleblind, placebo-controlled, cross-over study with the folowing questions: effectiveness on the other ratingscales (for example the NRS, BPI sleepingscale), 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 ;Timepoint(s) of evaluation of this end point: at the end of the study	—

Measure

Time frame

Secondary end point(s): Feasibility of a randomised, doubleblind, placebo-controlled, cross-over study with the folowing questions: effectiveness on the other ratingscales (for example the NRS, BPI sleepingscale), 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 ;Timepoint(s) of evaluation of this end point: at the end of the study

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Countries

Netherlands

Contacts

Public Contactphycisian assistant

Westfriesgasthuis

0031229208562

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026