Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
CompletedPhase 2NCT03664921
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.
Study details
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study Investigating the Safety and Efficacy of Omnitram in Diabetic Neuropathy
- Interventions
- Drug: Omnitram Oral Tablet
- Drug: Placebo Oral Tablet
- Sponsor
- Syntrix Biosystems, Inc.
- Collaborators
- DF/Net Research; National Institute on Drug Abuse (NIDA)
- Start date
- 2018-11-15
- Primary completion
- 2020-08-17
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male or female between the ages of 18 and 75 years of age. 2. Diabetes mellitus diagnosis for at least 6 months. 3. Total glycosylated hemoglobin of \<=12%. 4. Antidiabetic therapy used at screening will not be changed during the study. 5. Clinical diagnosis, confirmed by the Investigator, of painful diabetic neuropathy with symptoms and signs for at least 6 months. 6. Lower extremity pain, from diabetic neuropathy, present daily for the previous 3 months. 7. Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to \<=160mg of oral morphine. 8. Average neuropathic pain intensity over last 3 days before randomization (Segment 1, Study Day 1) of at least 4 on a 0-10 scale (0 = no pain; 10 = the worst possible pain). 9. Diabetic neuropathy confirmed by 1 of the following: * Clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes). * Electrophysiological tests (slowing of nerve conduction or reduction of amplitude of sensory action potential). * Abnormal quantitative sensory testing (reduction or absence of pin sensibility and/or vibration sensibility on Total Neuropathy Score - Nurse (TNSn) examination in lower and/or upper extremities at screening. 10. Able and willing to give informed consent. 11. Able to comply with all study procedures. 12. If female, must not be of childbearing potential or must agree to use one or more of the following forms of contraception during screening and for 30 days following study drug dosing: hormonal (e.g., oral, transdermal, intravaginal, implant or injection); double barrier (i.e., condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or abstinence; or bilateral tubal ligation (if no conception post-procedure). 13. Complete blood count (CBC) within normal range for the testing facility or not clinically significant. 14. Electrocardiogram (ECG), AST, ALT, and urinalysis values within the normal range for the testing facility or not clinically significant. 15. Normal renal function: Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula \> 60 ml/min. 16. Negative pregnancy test within 1 week of Segment 1, Study Day 1. 17. Negative urine test for substances of abuse per CRU standards. 18. Negative serology tests for HIV, hepatitis B surface antigen, and hepatitis C virus antibody. 19. Body Mass Index (BMI) 19.0 to 40 kg/m. Exclusion Criteria: …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03664921