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Nonsteroidal Anti-Inflammatory Drug
Celecoxib for Pain After Parotidectomy
Phase 2
Recruiting
Led By Tiffany Glazer, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to take oral medication
Undergoing superficial parotidectomy
Must not have
Concurrent use of CYP2C9 potentiator/inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Summary
This trial aims to see if pain after surgery can be controlled using celecoxib instead of oxycodone. Participants will take celecoxib or a placebo along with Tylenol and opioids as
Who is the study for?
This trial is for adults who can consent to treatment, take oral medication, and are undergoing a superficial parotidectomy. They must be willing to follow the study's procedures, keep a pain diary, complete questionnaires, and have good organ function as shown by blood tests.
What is being tested?
The trial is testing if celecoxib combined with Tylenol can manage pain after surgery and reduce the need for oxycodone. Participants will either receive celecoxib or a placebo alongside Tylenol and use opioids only if necessary.
What are the potential side effects?
Celecoxib may cause digestive issues like stomach pain or ulcers, kidney problems, increased risk of heart attack or stroke; Tylenol could lead to liver damage when overused; Oxycodone can result in addiction, respiratory issues or constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
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I am scheduled for a surgery to remove part of my salivary gland.
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I am 18 years old or older.
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My blood and organ function tests are within normal ranges.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication that affects how my body processes certain drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of oxycodone pills taken
Secondary study objectives
Change in pain scores
Drain duration
Number of post-operative complications
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Celecoxib for pain managementExperimental Treatment3 Interventions
Participants receive celecoxib in addition to Tylenol and oxycodone
Group II: Placebo for pain managementPlacebo Group3 Interventions
Participants receive placebo in addition to Tylenol and oxycodone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tylenol
2019
Completed Phase 4
~520
Celecoxib
2019
Completed Phase 4
~1740
Oxycodone
2014
Completed Phase 4
~2210
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,801 Total Patients Enrolled
Tiffany Glazer, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
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