Pain ManagementPhase 3NCT03395808
Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery
A Phase 3 study testing Tramadol in people with Pain Management, run by Avenue Therapeutics, Inc. at 1 site in United States.
Trial summary
The study evaluates the safety of IV tramadol managing post-operative pain following surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2017to 6 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is male or female 18-75 years of age
- Willing to give consent and able to understand the study procedures
- Female patients must be of non-childbearing potential or be practicing a highly effective contraption
- The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Who cannot join
- The patient has used chronic opioid therapy, defined as >= 20 MEQs of morphine per day >=3 days out of 7 days over the past 4 weeks.
- The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence.
- The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery.
- The patient has a history of epilepsy, is susceptible to seizures.
- The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, amphetamines).
- The patient has had a recent (within 6 months) cardiovascular event or clinically significant abnormal ECG finding at screening.
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- The patient has a history of Long QT Syndrome or a relative with this condition.
- The patient has expressed suicidal ideation within the past 3 months or is considered to be at risk of suicide.
- The patient is morbidly obese (body mass index [BMI] ≥ 40 kg/m2) or has documented sleep apnea requiring CPAP or other treatment.
- Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding.
- The patient has a history of cardiopulmonary, neurological or psychiatric condition that may confound the assessments of efficacy or safety.
- The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 3X upper limit of normal (ULN) at Screening.
- The patient has severe renal impairment or a serum creatinine value of > 2x upper limit of normal (ULN) at Screening.
- The patient has potassium, sodium, calcium or magnesium levels outside of the normal range at Screening.
- The patient has a hemoglobin level at screening which, in the judgment of the Investigator, is not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery
The study evaluates the safety of IV tramadol managing post-operative pain following surgery.
Read the detailed description
(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.
- Conditions
- Pain Management
- Being tested
- Tramadol
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
| Study group | Role | What they receive |
|---|---|---|
| AVE-901 50mg | Other | IV Tramadol Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Reported Adverse Events
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start22 Dec 2017
- Primary completion25 Apr 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain ManagementStudies 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 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avenue Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395808
- Sponsor's protocol ID
- AVE-901-104
- Status last verified
- Jun 2019
- First submitted
- 22 Dec 2017
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety of Tramadol Infusion (AVE-901) in the Management of Post-Operative Pain Following Surgery
- ClinicalTrials.gov ID
- NCT03395808
- Acronym / sponsor ID
- AVE-901-104
- Conditions
- Pain Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Avenue Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Posted 9 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the safety of IV tramadol managing post-operative pain following surgery.
Detailed description
(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVE-901 50mg | Other | Drug: TramadolIV Tramadol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is male or female 18-75 years of age
- Willing to give consent and able to understand the study procedures
- Female patients must be of non-childbearing potential or be practicing a highly effective contraption
- The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 24 hours after surgery
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Key exclusion criteria (15 listed)
- The patient has used chronic opioid therapy, defined as >= 20 MEQs of morphine per day >=3 days out of 7 days over the past 4 weeks.
- The patient has a recent (within 2 years) and/or current history of alcohol, opiate or tranquilizer abuse or dependence.
- The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 7 days prior to surgery.
- The patient has a history of epilepsy, is susceptible to seizures.
- The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, amphetamines).
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 |
|---|---|---|
| TramadolIV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses | Drug | AVE-901 50mg |
Primary outcome
Adverse Events
Time frame: Up to 21 days
Reported Adverse Events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol in people with Pain Management, run by Avenue Therapeutics, 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 5 inclusion and 15 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 9 Mar 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: Up to 21 days). 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 9 Mar 2021.