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Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy

NCT03664921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-09-30

No results posted yet for this study

Summary

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.

Conditions

  • Diabetic Neuropathies
  • Neuropathic Pain
  • Pain, Chronic

Interventions

DRUG

Omnitram Oral Tablet

Administered three times daily for 28 consecutive days.

DRUG

Placebo Oral Tablet

Administered three times daily for 28 consecutive days.

Sponsors & Collaborators

  • DF/Net Research

    collaborator UNKNOWN

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Syntrix Biosystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Kahn, MD · Syntrix Biosystems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2020-08-17
Completion
2020-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664921 on ClinicalTrials.gov