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:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00113620
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of diabetes mellitus
* Established diabetic therapy for at least 3 months
* Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
* Pain the previous three months
* Not pregnant
Exclusion Criteria:
* Patient failed adequate trial of 3 or more medications or has required narcotics for pain
* History of torsades de pointes
* Sensitivity to quinidine or opiate drugs (codeine, etc)
* Severe pain that could confound the assessment
* Patient has had any amputations
* Patient has participated in the past 30 days or is currently participating in another trial
* Patient has previously received treatment with dextromethorphan and quinidine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00113620
Study Brief:
Protocol Section:
NCT00113620