Pain ManagementPhase 3NCT03774836
Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty
A Phase 3 study testing Tramadol and Morphine in people with Pain Management, run by Avenue Therapeutics, Inc. at 3 sites in United States.
Trial summary
This study is evaluating the analgesic efficacy of intravenous (IV) tramadol (AVE-901) compared to placebo in the management of postoperative pain following abdominal 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 and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Dec 2018to 30 Jun 2019
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 48 hours after surgery
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Who cannot join
- The patient is undergoing an abdominoplasty of significant complexity defined as pre-planned surgical time of greater than 180 mins.
- The patient has a recent (within 5 years) and/or current history of chronic analgesic, opiate or tranquilizer abuse or dependence or is a user of illicit drugs or has had a recent history (within 2 years) of drug or alcohol abuse.
- 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 14 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, cyclobenzaprine triptans).
- The patient has had a recent cardiovascular event or clinically significant abnormal ECG finding at screening or baseline.
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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 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 or other medical 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 > 2.0 mg/dL at Screening.
- The patient has potassium, sodium, calcium or magnesium levels outside of the normal range or any other clinically significant abnormalities in laboratory values at Screening.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hermann Drive Research
Houston, Texas, 77004
Lotus Clinical Research
Pasadena, California, 91105
Endeavor Clinical Trials
San Antonio, Texas, 78229
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo and Morphine in the Management of Postoperative Pain Following Abdominoplasty
This study is evaluating the analgesic efficacy of intravenous (IV) tramadol (AVE-901) compared to placebo in the management of postoperative pain following abdominal surgery.
Read the detailed description
(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioid-like 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, Morphine, Placebo
- 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 Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
MorphineDrug
Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
PlaceboOther
Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
| Study group | Role | What they receive |
|---|---|---|
| Tramadol 50 mg | Active comparator | Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Receives: Drug: Tramadol |
| Morphine 4 mg | Active comparator | Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Receives: Drug: Morphine |
| Placebo | Placebo comparator | Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sum of Pain Intensity Differences through 24 hours
Measured: 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start14 Dec 2018
- Primary completion30 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avenue Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774836
- Sponsor's protocol ID
- AVE-901-103
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2018
- Last updated
- 9 May 2019
- Results posted
- No
- 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 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo and Morphine in the Management of Postoperative Pain Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT03774836
- Acronym / sponsor ID
- AVE-901-103
- Conditions
- Pain Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Avenue Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 13 Dec 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 is evaluating the analgesic efficacy of intravenous (IV) tramadol (AVE-901) compared to placebo in the management of postoperative pain following abdominal surgery.
Detailed description
(Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioid-like 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tramadol 50 mg | Active comparator | Drug: TramadolGiven at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Morphine 4 mg | Active comparator | Drug: MorphineGiven at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Placebo | Placebo comparator | Other: PlaceboGiven at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
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 48 hours after surgery
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Key exclusion criteria (14 listed)
- The patient is undergoing an abdominoplasty of significant complexity defined as pre-planned surgical time of greater than 180 mins.
- The patient has a recent (within 5 years) and/or current history of chronic analgesic, opiate or tranquilizer abuse or dependence or is a user of illicit drugs or has had a recent history (within 2 years) of drug or alcohol abuse.
- 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 14 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, cyclobenzaprine triptans).
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 Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 | Drug | Tramadol 50 mg |
| MorphineMorphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 | Drug | Morphine 4 mg |
| PlaceboPlacebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 | Other | Placebo |
Primary outcome
The Sum of Pain Intensity Differences through 24 hours
Time frame: 24 hours post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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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.
3 sites 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 and Morphine in people with Pain Management, run by Avenue Therapeutics, Inc. at 3 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 5 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: under way, not looking for participants, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
This study is still under way. Results are not available in the source record yet.
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?
The Sum of Pain Intensity Differences through 24 hours (time frame: 24 hours post dose). 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 May 2019.