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History of Changes for Study: NCT03290378
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
Latest version (submitted March 11, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 19, 2017 None (earliest Version on record)
2 October 9, 2017 Study Status, Contacts/Locations and Study Description
3 December 6, 2017 Study Status and Contacts/Locations
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Results Submission Events
4 March 11, 2020 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Study Design, Document Section and Results
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Study NCT03290378
Submitted Date:  September 19, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: AVE-901-102
Brief Title: Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2017
Overall Status: Recruiting
Study Start: September 19, 2017
Primary Completion: June 30, 2018 [Anticipated]
Study Completion: July 30, 2018 [Anticipated]
First Submitted: September 19, 2017
First Submitted that
Met QC Criteria:
September 19, 2017
First Posted: September 21, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 19, 2017
Last Update Posted: September 21, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Avenue Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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 (Grond and Sablotzki, 2004).

Open or close this module Conditions
Conditions: Pain Management
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 405 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Placebo
IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The Sum of Pain Intensity Differences (SPID) through 48 hours post first dose
[ Time Frame: 48 hours post first dose ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Michael Ryan, MS
Telephone: 781-652-4514
Email: mryan@fortressbiotech.com
Central Contact Backup: Amy Wheeler
Telephone: 781-652-4509
Email: awheeler@fortressbiotech.com
Locations: United States, California
Lotus Clinical Research
[Recruiting]
Pasadena, California, United States, 91105
Contact:Contact: Fardin Hakakian, DPM
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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