PainPhase 1NCT02205554
Omnitram Pharmacokinetic Study In Healthy Volunteers
A Phase 1 study testing Omnitram and Tramadol in people with Pain, run by Syntrix Biosystems, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Omnitram and Tramadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2014
- Phase
- Phase 1
- 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 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male with normal vital signs: systolic blood pressure > 90 mm Hg and < 140 mm Hg; diastolic blood pressure > 50 mm Hg and < 90 mm Hg; pulse 50 to 100 beats per minute; respiratory rate 12 to 20 breathes per minute
- Between the ages of 21 and 55 years of age
- Able and willing to give informed consent
- Able to comply with all study procedures
- Have adequate hematologic function as evidenced by the following screening results:
- White Blood Cell (WBC) >3,500/mm3 and < 12,000/mm3;
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- Platelet Count > 150,000/mm3 and < 540,000/mm3;
- Hemoglobin > 12.5 gm/dL and < 20.5 gm/dL.
- Have adequate liver function as evidenced by the following screening results:
- Aspartate transaminase (AST) ≤ 60 IU/L;
- Alanine transaminase (ALT) ≤ 83 IU;
- Alkaline Phosphatase ≤ 150 IU/L;
- Total Bilirubin ≤ 1.2 mg/dL;
- Prothrombin Time (PT) < 1.2 upper limit of normal (ULN); Partial Thromboplastin Time (PTT) < 1.2 ULN.
- Electrocardiogram (ECG) within normal limits as determined by the PI
- Have adequate renal function as evidenced by the following screening result:
- Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula >60 ml/min.
- Urinalysis demonstrating < +1 glucose, +1 ketones, and +1 protein
- Negative urine test for substances of abuse, including opiates, per clinical research unit (CRU) standards
- Negative serology tests for HIV, hepatitis B surface antigen and hepatitis C virus antibody
- Body Mass Index (BMI) 19.0 to 32 kg/m
- Cold pressor screening results as follows: 1) pain tolerance of > 20 seconds and <120 seconds
Who cannot join
- Oral temperature > 38°C or history of current illness
- History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head trauma, metabolic disorders, alcohol or drug withdrawal)
- History of cirrhosis or laboratory evidence of liver disease
- Use of alcohol within 24 hours of day -1 until the end of the study; and grapefruit, grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), or grapefruit juice or grapefruit-related juices, or other medication, within 7 days of study drug administration and until the end of the study
- History of previous anaphylaxis, severe allergic reaction to Tramadol, codeine, or other opioid drugs
- Use of monoamine oxidase (MAO) inhibitors (including linezolid), Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, and prescription or over-the counter (OTC) medications known to induce or inhibit drug metabolism, including cytochrome P450 2D6 (CYP2D6), and other drugs that may affect the serotonergic neurotransmitter systems including, but not limited to, triptans, dextromethorphan, tricyclic antidepressants, bupropion, lithium, tramadol, dietary supplements such as tryptophan and St. John's Wort, and antipsychotics or other dopamine antagonists. These restrictions are to be maintained from 14 days before study day -1, until the subject completes the study
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- 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 Medical Monitor
- Unlikely to comply with the study protocol
- Known or suspected alcohol or drug abuse within the past 6 months
- Received another investigational agent within 4 weeks of Day 0, or within five half-lives of Day 0, whichever is longer; 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 data
Trial locations and contacts
1 site in 1 country.
United States1 site
CRI Lifetree Research Center
Salt Lake City, Utah, 84106
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Triple Cross-Over Study Investigating The Safety, Oral Steady-State Pharmacokinetics, And Clinical Activity Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects
The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.
Read the detailed description
A Phase 1, single-center, randomized, double-blind, placebo-controlled, three-period cross-over study to compare the safety, steady-state oral pharmacokinetics, and clinical activity of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg Tramadol (1x50 mg Ultram tablet), and placebo.
Forty male subjects in normal health, 21 to 55 years of age, will be randomized to three parallel arms (N=~13 each) to ingest a total of 9 doses of Omnitram, Tramadol, or placebo in a first treatment segment (one dose every 6 hours). Around the 9th dose blood samples are collected to quantify plasma Tramadol and Metabolite 1 (M1) enantiomers. After the 9th dose, pain tolerance is assessed with a cold pressor test (ice cold water immersion). After the 7th dose abuse liability measures and pupil diameter will be assessed. Subjects will washout for 7 days after the first treatment segment and second treatment segment.
- Conditions
- Pain
- Being tested
- Omnitram, Tramadol, Placebo
- Keywords
- Analgesia, Pharmacokinetics, Treatment
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnitramDrug
Nine 20 mg doses administered every 6 hours
TramadolDrug
Nine 50 mg doses administered every 6 hours.
PlaceboDrug
Nine doses administered every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Omnitram-Tramadol-Placebo | Active comparator | Omnitram 20 mg every 6 hours for 9 doses, followed by Tramadol 50 mg every 6 hours for 9 doses, followed by Placebo every 6 hours for 9 doses. Receives: Drug: Omnitram; Drug: Tramadol; Drug: Placebo |
| Tramadol-Placebo-Omnitram | Active comparator | Tramadol 20 mg every 6 hours for 9 doses, followed by Placebo every 6 hours for 9 doses, followed by Omnitram 20 mg every 6 hours for 9 doses. Receives: Drug: Omnitram; Drug: Tramadol; Drug: Placebo |
| Placebo-Omnitram-Tramadol | Active comparator | Placebo every 6 hours for 9 doses, followed by Omnitram 20 mg every 6 hours for 9 doses, followed by Tramadol 50 mg every 6 hours for 9 doses. Receives: Drug: Omnitram; Drug: Tramadol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omnitram and Tramadol Steady State Maximum and Minimum Concentrations
Measured: 0.0, 1.0, 1.5, 2.0, 2.5, and 4.0 hours after the 9th dose of Omnitram and Tramadol.
Adverse events
Measured: 29 days
Secondary outcomes (2)
Cold Water Induced-Pain Reported On a 0 to 10 Scale
Subject immerses a hand in cold water for a maximum of 3 minutes and reports level of pain.
Measured: On Study Day 2, Study Day 12, and Study Day 22, after the 9th dose of Omnitram, Tramadol, and placebo.
Abuse Liability Assessed With Visual Analogue Scales
Subjects read a question and respond by placing a mark on a visual analogue scale.
Measured: On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntrix Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Shawn Searle, MD, Principal investigator, PRA/CRI Lifetree Research CenterStuart Kahn, MD, Study director, Syntrix Biosystems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205554
- Sponsor's protocol ID
- Syntrix-Omni-Pain-101
- Other IDs
- R44DA027304
- Status last verified
- Oct 2014
- First submitted
- 28 Jul 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Zebala JA, Searle SL, Webster LR, Johnson MS, Schuler AD, Maeda DY, Kahn SJ. Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. J Pain. 2019 Oct;20(10):1218-1235. doi: 10.1016/j.jpain.2019.04.005. Epub 2019 Apr 18.
PubMed 31005596
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Triple Cross-Over Study Investigating The Safety, Oral Steady-State Pharmacokinetics, And Clinical Activity Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects
- ClinicalTrials.gov ID
- NCT02205554
- Acronym / sponsor ID
- Syntrix-Omni-Pain-101
- Conditions
- Pain
- Keywords
- Analgesia, Pharmacokinetics, Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Syntrix Biosystems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 31 Jul 2014 (estimated)
- 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.
The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.
Detailed description
A Phase 1, single-center, randomized, double-blind, placebo-controlled, three-period cross-over study to compare the safety, steady-state oral pharmacokinetics, and clinical activity of overencapsulated: 20 mg Omnitram (2x10 mg tablets), 50 mg Tramadol (1x50 mg Ultram tablet), and placebo.
Forty male subjects in normal health, 21 to 55 years of age, will be randomized to three parallel arms (N=~13 each) to ingest a total of 9 doses of Omnitram, Tramadol, or placebo in a first treatment segment (one dose every 6 hours). Around the 9th dose blood samples are collected to quantify plasma Tramadol and Metabolite 1 (M1) enantiomers. After the 9th dose, pain tolerance is assessed with a cold pressor test (ice cold water immersion). After the 7th dose abuse liability measures and pupil diameter will be assessed. Subjects will washout for 7 days after the first treatment segment and second treatment segment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omnitram-Tramadol-Placebo | Active comparator | Drug: Omnitram, Drug: Tramadol, Drug: PlaceboOmnitram 20 mg every 6 hours for 9 doses, followed by Tramadol 50 mg every 6 hours for 9 doses, followed by Placebo every 6 hours for 9 doses. |
| Tramadol-Placebo-Omnitram | Active comparator | Drug: Omnitram, Drug: Tramadol, Drug: PlaceboTramadol 20 mg every 6 hours for 9 doses, followed by Placebo every 6 hours for 9 doses, followed by Omnitram 20 mg every 6 hours for 9 doses. |
| Placebo-Omnitram-Tramadol | Active comparator | Drug: Omnitram, Drug: Tramadol, Drug: PlaceboPlacebo every 6 hours for 9 doses, followed by Omnitram 20 mg every 6 hours for 9 doses, followed by Tramadol 50 mg every 6 hours for 9 doses. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Healthy male with normal vital signs: systolic blood pressure > 90 mm Hg and < 140 mm Hg; diastolic blood pressure > 50 mm Hg and < 90 mm Hg; pulse 50 to 100 beats per minute; respiratory rate 12 to 20 breathes per minute
- Between the ages of 21 and 55 years of age
- Able and willing to give informed consent
- Able to comply with all study procedures
- Have adequate hematologic function as evidenced by the following screening results:
Key exclusion criteria (11 listed)
- Oral temperature > 38°C or history of current illness
- History of seizures, epilepsy, or recognized increase risk of seizure (e.g., head trauma, metabolic disorders, alcohol or drug withdrawal)
- History of cirrhosis or laboratory evidence of liver disease
- Use of alcohol within 24 hours of day -1 until the end of the study; and grapefruit, grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), or grapefruit juice or grapefruit-related juices, or other medication, within 7 days of study drug administration and until the end of the study
- History of previous anaphylaxis, severe allergic reaction to Tramadol, codeine, or other opioid drugs
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 |
|---|---|---|
| OmnitramNine 20 mg doses administered every 6 hours | Drug | Omnitram-Tramadol-Placebo, Placebo-Omnitram-Tramadol, Tramadol-Placebo-Omnitram |
| TramadolNine 50 mg doses administered every 6 hours. | Drug | Omnitram-Tramadol-Placebo, Placebo-Omnitram-Tramadol, Tramadol-Placebo-Omnitram |
| PlaceboNine doses administered every 6 hours. | Drug | Omnitram-Tramadol-Placebo, Placebo-Omnitram-Tramadol, Tramadol-Placebo-Omnitram |
Primary outcome
Omnitram and Tramadol Steady State Maximum and Minimum Concentrations
Time frame: 0.0, 1.0, 1.5, 2.0, 2.5, and 4.0 hours after the 9th dose of Omnitram and Tramadol.
Adverse events
Time frame: 29 days
2 secondary outcomes
Cold Water Induced-Pain Reported On a 0 to 10 Scale
Time frame: On Study Day 2, Study Day 12, and Study Day 22, after the 9th dose of Omnitram, Tramadol, and placebo.
Abuse Liability Assessed With Visual Analogue Scales
Time frame: On Study Day 1, Study Day 11, and Study Day 21, after the 7th dose of Omnitram, Tramadol, and placebo.
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 15 Oct 2014.
- Derived from this study: PubMed 31005596Zebala JA, Searle SL, Webster LR, Johnson MS, Schuler AD, Maeda DY, Kahn SJ. Desmetramadol Has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. J Pain. 2019 Oct;20(10):1218-1235. doi: 10.1016/j.jpain.2019.04.005. Epub 2019 Apr 18.
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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.
Shawn Searle, MD principal investigator
PRA/CRI Lifetree Research Center
Stuart Kahn, MD study director
Syntrix Biosystems, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omnitram and Tramadol in people with Pain, run by Syntrix Biosystems, Inc. at 1 site 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 11 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Omnitram and Tramadol Steady State Maximum and Minimum Concentrations (time frame: 0.0, 1.0, 1.5, 2.0, 2.5, and 4.0 hours after the 9th dose of Omnitram and Tramadol.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02205554, which also lists 1 linked publication.
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 15 Oct 2014.