Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
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| ClinicalTrials.gov Identifier: NCT03290378 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2017
Last Update Posted : December 8, 2017
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Sponsor:
Avenue Therapeutics, Inc.
Information provided by (Responsible Party):
Avenue Therapeutics, Inc.
- Study Details
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- No Results Posted
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Brief Summary:
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain Management | Drug: Tramadol Other: Placebo | Phase 3 |
(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 (Clinical Trial) |
| Estimated Enrollment : | 405 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 19, 2017 |
| Estimated Primary Completion Date : | June 30, 2018 |
| Estimated Study Completion Date : | July 30, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Tramadol
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: AVE-901 50 mg |
Drug: Tramadol
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 |
Drug: Tramadol
IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
| Placebo Comparator: Placebo |
Other: Placebo
IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44 |
Primary Outcome Measures :
- The Sum of Pain Intensity Differences (SPID) through 48 hours post first dose [ Time Frame: 48 hours post first dose ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290378
Contacts
| Contact: Michael Ryan, MS | 781-652-4514 | mryan@fortressbiotech.com | |
| Contact: Amy Wheeler | 781-652-4509 | awheeler@fortressbiotech.com |
Locations
| United States, California | |
| Trovare Clinical Research | Recruiting |
| Bakersfield, California, United States, 93301 | |
| Contact: John Zimmerman, DPM 661-663-3096 | |
| Principal Investigator: John Zimmerman, DPM | |
| Lotus Clinical Research | Recruiting |
| Pasadena, California, United States, 91105 | |
| Contact: Fardin Hakakian, DPM | |
| United States, Maryland | |
| Cheseapeake Research Group, LLC | Recruiting |
| Pasadena, Maryland, United States, 21122 | |
| Contact: Ira Gottlieb, DPM 410-761-0118 | |
| United States, Texas | |
| H.D. Research Corporation | Recruiting |
| Houston, Texas, United States, 77004 | |
| Contact: David Leiman, MD 713-894-4840 | |
| Endeavor Clinical Trials, PA | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Richard Pollak, DPM 210-949-0807 | |
Sponsors and Collaborators
Avenue Therapeutics, Inc.
| Responsible Party: | Avenue Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT03290378 History of Changes |
| Other Study ID Numbers: |
AVE-901-102 |
| First Posted: | September 21, 2017 Key Record Dates |
| Last Update Posted: | December 8, 2017 |
| Last Verified: | December 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
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Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Tramadol |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |