- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03290378
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
March 11, 2020 updated by: Avenue Therapeutics, Inc.
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
Study Overview
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 Type
Interventional
Enrollment (Actual)
409
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Bakersfield, California, United States, 93301
- Trovare Clinical Research
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Pasadena, California, United States, 91105
- Lotus Clinical Research
-
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Maryland
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Pasadena, Maryland, United States, 21122
- Cheseapeake Research Group, LLC
-
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Texas
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Houston, Texas, United States, 77004
- H.D. Research Corporation
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San Antonio, Texas, United States, 78229
- Endeavor Clinical Trials, PA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
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IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
ACTIVE_COMPARATOR: AVE-901 50 mg
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IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
ACTIVE_COMPARATOR: AVE-901 25 mg
|
IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
48 hours post first dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 19, 2017
Primary Completion (ACTUAL)
April 11, 2018
Study Completion (ACTUAL)
April 23, 2018
Study Registration Dates
First Submitted
September 19, 2017
First Submitted That Met QC Criteria
September 19, 2017
First Posted (ACTUAL)
September 21, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVE-901-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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