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Evaluate Safety of Tramadol in the Management of Postoperative Pain Following Surgery

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: NCT03395808
Recruitment Status : Completed
First Posted : January 10, 2018
Results First Posted : March 9, 2021
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Avenue Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Pain Management
Intervention Drug: Tramadol
Enrollment 251
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AVE-901 50mg
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IV Tramadol

Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses

Period Title: Overall Study
Started 251
Completed 251
Not Completed 0
Arm/Group Title AVE-901 50mg
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IV Tramadol

Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses

Overall Number of Baseline Participants 251
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[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
<=18 years
0
   0.0%
Between 18 and 65 years
201
  80.1%
>=65 years
50
  19.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
Female
151
  60.2%
Male
100
  39.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
Hispanic or Latino
85
  33.9%
Not Hispanic or Latino
166
  66.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
43
  17.1%
White
203
  80.9%
More than one race
1
   0.4%
Unknown or Not Reported
1
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 251 participants
251
1.Primary Outcome
Title Adverse Events
Hide Description Reported Adverse Events
Time Frame Up to 21 days
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Tramadol 50 mg
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50 mg IV tramadol given at 0, 2, 4 hours and every 4 hours after
Overall Number of Participants Analyzed 251
Measure Type: Count of Participants
Unit of Measure: Participants
251
 100.0%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AVE-901 50mg
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IV Tramadol

Tramadol: IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses

All-Cause Mortality
AVE-901 50mg
Affected / at Risk (%)
Total   0/251 (0.00%)    
Hide Serious Adverse Events
AVE-901 50mg
Affected / at Risk (%) # Events
Total   2/251 (0.80%)    
Investigations   
Post procedural hematoma *  2/251 (0.80%)  2
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AVE-901 50mg
Affected / at Risk (%) # Events
Total   149/251 (59.36%)    
Gastrointestinal disorders   
Nausea *  72/251 (28.69%) 
Vomitting *  49/251 (19.52%) 
Constipation *  14/251 (5.58%) 
General disorders   
Infusion Site pain *  13/251 (5.18%) 
Investigations   
Blood creatine phosphokinase increased *  16/251 (6.37%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia *  17/251 (6.77%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Micheal Ryan, VP Clinical
Organization: Avenue Therapeutics
Phone: 781-652-4514
EMail: mryan@avenuetx.com
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Responsible Party: Avenue Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03395808    
Other Study ID Numbers: AVE-901-104
First Submitted: December 22, 2017
First Posted: January 10, 2018
Results First Submitted: February 16, 2021
Results First Posted: March 9, 2021
Last Update Posted: March 9, 2021