Description:

ODM derived from http://clinicaltrials.gov/show/NCT00322621

Link:

http://clinicaltrials.gov/show/NCT00322621

Keywords:
Versions (3) ▾
  1. 3/21/12
  2. 3/19/14
  3. 8/11/14
Uploaded on:

August 11, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY 4.0
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Eligibility NCT00322621 Diabetic Neuropathies

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age 18 Years and older
Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
Exclusion Criteria
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study.
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
Fluoxetine
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.