Pain ManagementPhase 3NCT03290378
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
A Phase 3 study testing Tramadol in people with Pain Management, run by Avenue Therapeutics, Inc. at 5 sites in United States.
Trial summary
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Sep 2017to 23 Apr 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is male or female 18-75 years of age undergoing unilateral first metatarsal bunionectomy surgery
- 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 contraception
- The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 72 hours after surgery.
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Who cannot join
- Patient is not expected to receive a continuous infusion nerve block as described in the Post-Op anesthetic procedures protocol
- Patient is undergoing bilateral or revision bunionectomy surgery
- The patient has allergy or hypersensitivity (or is intolerant) to opioids or tramadol The patient has known physical dependence on opioids
- The patient has taken other prior/concurrent chronic medications that have not been at a stable dose for at least 2 weeks prior to screening
- The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 or inducers of CYP3A4
- The patient has taken monoamine oxidase (MAO) inhibitors, trazodone, or cyclobenzaprine within 14 days prior to surgery
Show all 14Show fewer
- The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase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).
- The patient has a history of epilepsy, or is known to be susceptible to seizures
- 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 pharmacological or device intervention.
- Clinically significant abnormalities in the judgement of the Investigator
- The patient was administered an investigational product within 30 days prior to Screening.
- The patient has previously participated in a clinical study with AVE-901.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Trovare Clinical Research
Bakersfield, California, 93301
H.D. Research Corporation
Houston, Texas, 77004
Lotus Clinical Research
Pasadena, California, 91105
Cheseapeake Research Group, LLC
Pasadena, Maryland, 21122
Endeavor Clinical Trials, PA
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 in the Management of Postoperative Pain Following Bunionectomy
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
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, 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; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
PlaceboOther
IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
| Study group | Role | What they receive |
|---|---|---|
| AVE-901 50 mg | Active comparator | Not described Receives: Drug: Tramadol |
| AVE-901 25 mg | Active comparator | Not described Receives: Drug: Tramadol |
| Placebo | Placebo comparator | Not described 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 (SPID) Through 48 Hours Post First Dose
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.
Measured: 48 hours post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start19 Sep 2017
- Primary completion11 Apr 2018
- Study completion23 Apr 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 409 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
- NCT03290378
- Sponsor's protocol ID
- AVE-901-102
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2017
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Singla NK, Pollak R, Gottlieb I, Leiman D, Minkowitz H, Zimmerman J, Harnett M, Ryan M, Lu L, Reines S. Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study. Pain Ther. 2020 Dec;9(2):545-562. doi: 10.1007/s40122-020-00184-2. Epub 2020 Jul 18.
PubMed 32683644
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. 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 in the Management of Postoperative Pain Following Bunionectomy
- ClinicalTrials.gov ID
- NCT03290378
- Acronym / sponsor ID
- AVE-901-102
- Conditions
- Pain Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Avenue Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Posted 19 Mar 2020
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 effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AVE-901 50 mg | Active comparator | Drug: Tramadol |
| AVE-901 25 mg | Active comparator | Drug: Tramadol |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient is male or female 18-75 years of age undergoing unilateral first metatarsal bunionectomy surgery
- 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 contraception
- The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 72 hours after surgery.
- The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
Key exclusion criteria (14 listed)
- Patient is not expected to receive a continuous infusion nerve block as described in the Post-Op anesthetic procedures protocol
- Patient is undergoing bilateral or revision bunionectomy surgery
- The patient has allergy or hypersensitivity (or is intolerant) to opioids or tramadol The patient has known physical dependence on opioids
- The patient has taken other prior/concurrent chronic medications that have not been at a stable dose for at least 2 weeks prior to screening
- The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 or inducers of CYP3A4
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; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 | Drug | AVE-901 25 mg, AVE-901 50 mg |
| PlaceboIV; Placebo, 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 (SPID) Through 48 Hours Post First Dose
Time frame: 48 hours post first dose
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32683644Singla NK, Pollak R, Gottlieb I, Leiman D, Minkowitz H, Zimmerman J, Harnett M, Ryan M, Lu L, Reines S. Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study. Pain Ther. 2020 Dec;9(2):545-562. doi: 10.1007/s40122-020-00184-2. Epub 2020 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 in people with Pain Management, run by Avenue Therapeutics, Inc. at 5 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: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 19 Mar 2020). 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?
The Sum of Pain Intensity Differences (SPID) Through 48 Hours Post First Dose (time frame: 48 hours post first dose). 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 NCT03290378, 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 19 Mar 2020.