A pilot study on the effect of ARA290 on pain and pain responses and retinal edema in patients with diabetes mellitus and neuropathic pai
- Conditions
- europathic painMedDRA version: 12.1Level: LLTClassification code 10054095Term: Neuropathic pain
- Registration Number
- EUCTR2010-021518-45-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(i) Patients diagnosed with small-fiber neuropathy according to the guidelines of the IASP or other professional pain societies (eg., Netherlands Society of Anesthesiologists); (ii) a pain score of 5 or higher; (iii) age between 18 and 75 years; (iv) being able to give written informed consent.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Female patients that are pregnant or lactating will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the effectiveness of ARA290 in the treatment of pain in neuropathic pain patients;Secondary Objective: -;Primary end point(s): pain relief using a Visual Analogue Score (VAS) sying the 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method