Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT01263132
Eligibility Criteria:
Inclusion Criteria:
* Subjects diagnosed with diabetes mellitus type 2
* Subjects with a history of neuropathic pain in the last 3 Months
* Men and women in reproductive age with a family planning method
* Subjects aged between 18 to 70 years
* Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%
* Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit
Exclusion Criteria:
* Subjects diagnosed as being pregnant or in state of lactation
* Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min
* Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes
* Subjects who are being pharmacologically treated for epilepsy
* Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes
* Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study
* Subjects with any orthopaedic alteration of any extremity
* Subjects with peripheral artery disease
* Subjects taking more than two neuropathic pain medicines
* Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse
* Subjects with acid-peptic disease
* Subjects with history of neoplasm of any type
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01263132
Study Brief:
Protocol Section:
NCT01263132