Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

409 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-19

Study Completion Date

2018-04-23

Brief Summary

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The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy

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Detailed Description

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(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

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AVE-901 50 mg

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

AVE-901 25 mg

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Interventions

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Tramadol

IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Intervention Type DRUG

Placebo

IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No