Diabetic NeuropathiesPhase 2NCT03664921
Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
A Phase 2 study testing Omnitram Oral Tablet in people with Diabetic Neuropathies and Neuropathic Pain, run by Syntrix Biosystems, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathies, Neuropathic Pain, Pain, Chronic
- What is being tested?
- Omnitram Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Nov 2018to 17 Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- Complete blood count (CBC) within normal range for the testing facility or not clinically significant.
- Electrocardiogram (ECG), AST, ALT, and urinalysis values within the normal range for the testing facility or not clinically significant.
- Normal renal function: Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula > 60 ml/min.
- Negative pregnancy test within 1 week of Segment 1, Study Day 1.
- Negative urine test for substances of abuse per CRU standards.
- Negative serology tests for HIV, hepatitis B surface antigen, and hepatitis C virus antibody.
- Body Mass Index (BMI) 19.0 to 40 kg/m.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Orange County Research Institute
Anaheim, California, 92801
Core Healthcare Group
Cerritos, California, 90703
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229
St. Louis Clinical Trials
St Louis, Missouri, 63141
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study Investigating the Safety and Efficacy of Omnitram in Diabetic Neuropathy
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.
Read the detailed description
A multi-centered, randomized, double-blind, placebo-controlled, two-period cross-over study to compare the safety and efficacy of Omnitram (30 mg to 120 mg daily) and placebo in patients with painful diabetic polyneuropathy. For subjects receiving treatment for neuropathic pain prior to study enrollment, their treatment will be tapered and stopped at least 2 weeks before they will be enrolled. Approximately fifty subjects will be randomized in a double-blind manner to a 4-week treatment period of Omnitram or placebo. After a washout of at least one week, patients will cross-over to the other treatment for a second 4 week treatment period with Omnitram or placebo.
During the first two weeks of each treatment period, guided by efficacy and tolerability, the dose will be increased from 3 tablets to 12 tablets per day given in three equal doses at approximately at 8 am, 2 pm and 8 pm (i.e., if the tablet is Omnitram, 30, 60, 90 or 120 mg/day). During the final two weeks of the treatment period, the doses will be kept constant at the highest tolerated titrated dose. Up to six tablets daily of 500 mg oral acetaminophen can be used as rescue medication except on the last 4 days of each treatment segment (Days 26, 27, 28, and 29).
- Conditions
- Diabetic Neuropathies, Neuropathic Pain, Pain, Chronic
- Being tested
- Omnitram Oral Tablet, Placebo Oral Tablet
- Keywords
- Analgesia
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnitram Oral TabletDrug
Administered three times daily for 28 consecutive days.
Placebo Oral TabletDrug
Administered three times daily for 28 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Scale
Subjects rate their pain intensity on a scale from 0 = no pain to 10 = worst possible pain
Measured: up to 28 days of each treatment.
Secondary outcomes (7)
Neuropathic Pain Symptom Inventory
Subjects complete the questionnaire.
Measured: The questionnaire is completed at Day 1 and Day 29 of both treatments.
Sleep Problem Scale
Subjects complete the questionnaire.
Measured: The questionnaire is completed at Day 1 and Day 29 of both treatments.
Major Depression Inventory
Subjects complete the questionnaire.
Measured: The questionnaire is completed at Day 1 and Day 29 of both treatments.
Global Assessment of Treatment
Independently the subject and Investigator assess the treatment on a 5-point scale (excellent, very good, good, fair, poor).
Measured: The assessment is completed on Day 29 of both treatments.
Global Impression of Change
The subject assesses overall change on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).
Measured: The assessment is completed on Day 29 of both treatments.
Average Daily Use of Acetaminophen
Subjects may use a maximum of 3 grams of acetaminophen each day.
Measured: Day 1 through Day 25 of both treatments.
Adverse Events
Adverse events include: 1) reports by subjects; and 2) observations by investigators.
Measured: Subjects report adverse events throughout study enrollment; investigators observe adverse events during subject clinic visits on Day 7 and Day 29 of each treatment, and at the final safety visit 2 weeks after the completing both treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start15 Nov 2018
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntrix Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DF/Net Research, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stuart Kahn, MD, Study director, Syntrix Biosystems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664921
- Sponsor's protocol ID
- Omni-Pain-201
- Other IDs
- 5R44DA040378-03
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study Investigating the Safety and Efficacy of Omnitram in Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT03664921
- Acronym / sponsor ID
- Omni-Pain-201
- Conditions
- Diabetic Neuropathies, Neuropathic Pain, Pain, Chronic
- Keywords
- Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Syntrix Biosystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DF/Net Research, National Institute on Drug Abuse (NIDA)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A multi-centered, randomized, double-blind, placebo-controlled, two-period cross-over study to compare the safety and efficacy of Omnitram (30 mg to 120 mg daily) and placebo in patients with painful diabetic polyneuropathy. For subjects receiving treatment for neuropathic pain prior to study enrollment, their treatment will be tapered and stopped at least 2 weeks before they will be enrolled. Approximately fifty subjects will be randomized in a double-blind manner to a 4-week treatment period of Omnitram or placebo. After a washout of at least one week, patients will cross-over to the other treatment for a second 4 week treatment period with Omnitram or placebo.
During the first two weeks of each treatment period, guided by efficacy and tolerability, the dose will be increased from 3 tablets to 12 tablets per day given in three equal doses at approximately at 8 am, 2 pm and 8 pm (i.e., if the tablet is Omnitram, 30, 60, 90 or 120 mg/day). During the final two weeks of the treatment period, the doses will be kept constant at the highest tolerated titrated dose. Up to six tablets daily of 500 mg oral acetaminophen can be used as rescue medication except on the last 4 days of each treatment segment (Days 26, 27, 28, and 29).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnitram | Experimental | Drug: Omnitram Oral TabletOral 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. |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletOral 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnitram Oral TabletAdministered three times daily for 28 consecutive days. | Drug | Omnitram |
| Placebo Oral TabletAdministered three times daily for 28 consecutive days. | Drug | Placebo |
Primary outcome
Numeric Pain Scale
Time frame: up to 28 days of each treatment.
Subjects rate their pain intensity on a scale from 0 = no pain to 10 = worst possible pain
7 secondary outcomes
Neuropathic Pain Symptom Inventory
Time frame: The questionnaire is completed at Day 1 and Day 29 of both treatments.
Sleep Problem Scale
Time frame: The questionnaire is completed at Day 1 and Day 29 of both treatments.
Major Depression Inventory
Time frame: The questionnaire is completed at Day 1 and Day 29 of both treatments.
Global Assessment of Treatment
Time frame: The assessment is completed on Day 29 of both treatments.
Global Impression of Change
Time frame: The assessment is completed on Day 29 of both treatments.
Average Daily Use of Acetaminophen
Time frame: Day 1 through Day 25 of both treatments.
Adverse Events
Time frame: Subjects report adverse events throughout study enrollment; investigators observe adverse events during subject clinic visits on Day 7 and Day 29 of each treatment, and at the final safety visit 2 weeks after the completing both treatments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Kahn, MD study director
Syntrix Biosystems
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omnitram Oral Tablet in people with Diabetic Neuropathies and Neuropathic Pain, run by Syntrix Biosystems, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Scale (time frame: up to 28 days of each treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.