Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy

NCT03664921 | Completed Phase 2 FDA Drug

• 2 other identifiers: Omni-Pain-2015R44DA040378-03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Analgesia

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Scale

  Subjects rate their pain intensity on a scale from 0 = no pain to 10 = worst possible pain

  up to 28 days of each treatment.

Secondary Outcomes (7)

• Neuropathic Pain Symptom Inventory

  The questionnaire is completed at Day 1 and Day 29 of both treatments.

• Sleep Problem Scale

  The questionnaire is completed at Day 1 and Day 29 of both treatments.

• Major Depression Inventory

  The questionnaire is completed at Day 1 and Day 29 of both treatments.

• Global Assessment of Treatment

  The assessment is completed on Day 29 of both treatments.

• Global Impression of Change

  The assessment is completed on Day 29 of both treatments.

Study Arms (2)

Omnitram

EXPERIMENTAL

Oral Omnitram (10 mg tablets) dosed three times daily. During the first two weeks each dose will be titrated between 1 tablet (10 mg) and 4 tablets (40 mg) to provide pain relief. The doses administered at the end of two weeks will be maintained during the final two weeks of treatment.

Drug: Omnitram Oral Tablet

Placebo

PLACEBO COMPARATOR

Oral placebo (tablets) dosed three times daily. During the first two weeks each dose will be titrated between 1 tablet and 4 tablets to provide pain relief. The doses administered at the end of two weeks will be maintained during the final two weeks of treatment.

Drug: Placebo Oral Tablet

Interventions

Omnitram Oral Tablet DRUG

Administered three times daily for 28 consecutive days.

Omnitram

Placebo Oral Tablet DRUG

Administered three times daily for 28 consecutive days.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female between the ages of 18 and 75 years of age.
• Diabetes mellitus diagnosis for at least 6 months.
• Total glycosylated hemoglobin of \<=12%.
• Antidiabetic therapy used at screening will not be changed during the study.
• Clinical diagnosis, confirmed by the Investigator, of painful diabetic neuropathy with symptoms and signs for at least 6 months.
• Lower extremity pain, from diabetic neuropathy, present daily for the previous 3 months.
• Patients currently requiring opioid treatment must be taking daily doses of an opioid-based analgesic equivalent to \<=160mg of oral morphine.
• 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).
• 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.
• Able and willing to give informed consent.
• Able to comply with all study procedures.
• 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).

You may not qualify if:

• Clinically significant abnormal vital signs including oral temperature \> 38°C or history of current illness.
• Inability to exclude other causes of polyneuropathy including: alcoholism, vitamin B12 deficiency, endocrinopathies, vasculitides, heavy metal exposure, drug use, and malignancy (direct or paraneoplastic).
• History of seizures, epilepsy, or recognized increase risk of seizure (e.g. head trauma, metabolic disorders, alcohol and drug withdrawal).
• History of cirrhosis or laboratory evidence of liver disease.
• Use of serotonergic drugs and drugs that impair serotonin metabolism (e.g., mirtazapine, trazodone); monoamine oxidase inhibitors, including linezolid, methylene blue; serotonin and norepinephrine reuptake inhibitors, except fluoxetine, within 14 days of Segment 1, Study Day 1 or during the study, use of fluoxetine within 28 days of Segment 1, Study Day 1, or during the study; and selective serotonin re-uptake inhibitors. Use of tricyclic antidepressants and other tricyclic drugs including cyclobenzaprine and promethazine; triptans; 5-HT3 receptor antagonists; neuroleptics. Use of benzodiazepines or other central nervous system depressants including non-benzodiazepine sedative hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics within 14 days of Segment 1, Study Day 1, or during the study. Use of opiates, including tramadol, within 28 days of Segment 1, Study Day 1, or during the study. Use of all other analgesics, except acetaminophen, within 14 days of Segment 1, Study Day 1, or during the study.
• History of previous anaphylaxis, severe allergic reaction to tramadol, codeine or other opioid drugs.
• Contraindication to use of opioids, tramadol, or acetaminophen.
• Use of non-pharmacological pain therapy.
• Any other unstable acute or chronic disease that could interfere with the evaluation of the safety of the study drug as determined by the principal Investigator in dialogue with the Sponsor's Medical Monitor.
• Currently pregnant or breast-feeding a child.
• Unlikely to comply with the study protocol.
• Known or suspected alcohol or drug abuse within the past 12 months.
• Received another investigational agent within 4 weeks before screening visit, or receiving any other investigational agent during this study.
• Any concurrent disease or condition that in the opinion of the investigator impairs the subject's ability to complete the trial. Psychological, familial, sociological, geographical or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.

Sponsors & Collaborators

• Syntrix Biosystems, Inc.: lead
• DF/Net Research: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Core Healthcare Group

Cerritos, California, 90703, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63141, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Stuart Kahn, MD

  Syntrix Biosystems

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: November 15, 2018
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: September 30, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)