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

• Conditions: Patients with peripheral neuropathic pain or scar pain; MedDRA version: 17.1Level: PTClassification code 10049002Term: Scar painSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 17.1Level: LLTClassification code 10029181Term: Nerve painSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-005656-26-NL
• Lead Sponsor: Westfriesgasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-19
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- peripheral neuropatic pain (DOT: 130)
- =18 year, competent
- =5 en <10 on the numeric rating scale
- max. 10% total body surface
- in %, 1 sole: 1¾, , 1 feet: 3½, 2 feet: 7, both legs to quarter onderlegs 10, 1 hand: 3)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br><br> ;Timepoint(s) of evaluation of this end point: at the end of the study