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Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03774836
Recruitment Status : Active, not recruiting
First Posted : December 13, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Avenue Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 11, 2018
First Posted Date  ICMJE December 13, 2018
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE December 14, 2018
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
The Sum of Pain Intensity Differences through 24 hours [ Time Frame: 24 hours post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03774836 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tramadol Versus Placebo and Morphine in the Management of Post-Operative Pain Abdominoplasty
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo and Morphine in the Management of Postoperative Pain Following Abdominoplasty
Brief Summary This study is evaluating the analgesic efficacy of intravenous (IV) tramadol (AVE-901) compared to placebo in the management of postoperative pain following abdominal surgery.
Detailed Description (Non-clinical summary) Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioid-like 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain Management
Intervention  ICMJE
  • Drug: Tramadol
    IV Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
  • Drug: Morphine
    Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
  • Other: Placebo
    Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
Study Arms  ICMJE
  • Active Comparator: Tramadol 50 mg
    Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
    Intervention: Drug: Tramadol
  • Active Comparator: Morphine 4 mg
    Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
    Intervention: Drug: Morphine
  • Placebo Comparator: Placebo
    Given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is male or female 18-75 years of age
  • 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 contraption
  • The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 48 hours after surgery
  • The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.

Exclusion Criteria:

  • The patient is undergoing an abdominoplasty of significant complexity defined as pre-planned surgical time of greater than 180 mins.
  • The patient has a recent (within 5 years) and/or current history of chronic analgesic, opiate or tranquilizer abuse or dependence or is a user of illicit drugs or has had a recent history (within 2 years) of drug or alcohol abuse.
  • The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 (e.g., fluoxetine, paroxetine, amitriptyline, quinidine, ketoconazole, erythromycin, grapefruit juice) or inducers of CYP3A4 (e.g., carbamazepine, rifampin, St. John's Wort) and cannot go through a minimum washout period of 14 days prior to surgery.
  • The patient has a history of epilepsy, is susceptible to seizures.
  • 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, cyclobenzaprine triptans).
  • The patient has had a recent cardiovascular event or clinically significant abnormal ECG finding at screening or baseline.
  • 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 CPAP or other treatment.
  • Female patient is pregnant and/or undergoing a pregnancy-related surgery, or breastfeeding.
  • The patient has a history of cardiopulmonary, neurological or psychiatric or other medical condition that may confound the assessments of efficacy or safety.
  • The patient has cirrhosis, moderate or severe hepatic impairment or an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 3X upper limit of normal (ULN) at Screening.
  • The patient has severe renal impairment or a serum creatinine value of > 2.0 mg/dL at Screening.
  • The patient has potassium, sodium, calcium or magnesium levels outside of the normal range or any other clinically significant abnormalities in laboratory values at Screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03774836
Other Study ID Numbers  ICMJE AVE-901-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avenue Therapeutics, Inc.
Study Sponsor  ICMJE Avenue Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avenue Therapeutics, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP