This trial is examining the effectiveness of new drug Omnitram to relieve pain in painful diabetic nerve disease. The main outcome to be measured will be pain intensity. This study will be carried out in Missouri and Texas, United States.
The details
Diabetic nerve disease (neuropathy) is a common complication of diabetes. When there are high glucose levels in the blood it can cause nerves to not function properly. This can be very painful which reduces the quality of life of patients.
The aim of this study is to examine the effectiveness of a new drug Omnitram in reducing pain in patients with painful diabetic nerve disease. The main outcome to be measured will be pain intensity.
Who are they looking for?
This study is enrolling 50 patients with a diagnosis of diabetes for at least 6 months. They should have a HbA1c of less than or equal to 12%. Patients must have confirmed painful diabetic nerve disease in the legs. Patients who are taking daily opioid pain relief must be taking daily doses of less than or equal to 160mg oral morphine. Female patients of childbearing age must be willing to use contraception forms approved by the investigator during the study and for 30 days following the study. Patients must have normal liver, kidney and heart function and normal blood counts. They should also be negative for HIV, Hepatitis B, and C.
Patients must not have nerve disease due to any other causes. Patients must not have a history of seizures or epilepsy and must not have taken pain drugs (except acetaminophen), benzodiazepines, anti-anxiety drugs, muscle relaxants, or psychiatric drugs for 14 days prior to the study. Patients must not have a serious allergy or a contraindication to acetaminophen or any opioid drugs. Patients must not be using any non-pharmacological pain therapy.
How will it work
Patients will be divided into two groups. One group will receive Omnitram tablets three times a day. The other group will receive a placebo tablet three times a day. Treatment will be given for 4 weeks. During the first 2 weeks, the treatment dose can vary from 1 to 4 tablets per day to provide pain relief. During the final 2 weeks, the dose will remain constant at the highest tolerated dose.
After 4 weeks, both groups will stop treatment for at least a week. After this, patients will swap groups for another 4 weeks of treatment. The main outcome to be measured will be pain intensity on a pain scale from 0 (no pain) to 10 (worst possible pain). Other outcomes to be measured will be pain symptoms, sleep problems and depression (measured by questionnaires).
