NCT06505187

Brief Summary

The goal of this clinical trial is to find out whether pain can be managed after an operation with celecoxib instead of oxycodone. The main question it aims to answer is if use of celecoxib plus Tylenol reduces the need for oxycodone. Researchers will compare the combination of celecoxib and Tylenol to a placebo to find out whether celecoxib works to manage pain. Participants will:

  • Take celecoxib, or a placebo, plus Tylenol with opioids as needed
  • Keep a diary of their pain between visits
  • Complete questionnaires

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
4mo left

Started Feb 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2025Sep 2026

First Submitted

Initial submission to the registry

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

July 10, 2024

Last Update Submit

December 2, 2025

Conditions

Parotidectomy

Outcome Measures

Primary Outcomes (1)

  • Number of oxycodone pills taken

    Total number of oxycodone pills taken during the first 7 days post-operative

    7 days

Secondary Outcomes (4)

  • Change in pain scores

    Baseline (post-operative) to 7 days

  • Side effects from medications

    7 days

  • Drain duration

    7 days

  • Number of post-operative complications

    7 days

Study Arms (2)

Celecoxib for pain management

EXPERIMENTAL

Participants receive celecoxib in addition to Tylenol and oxycodone

Drug: CelecoxibDrug: TylenolDrug: Oxycodone

Placebo for pain management

SHAM COMPARATOR

Participants receive placebo in addition to Tylenol and oxycodone

Drug: TylenolDrug: OxycodoneDrug: placebo

Interventions

CelecoxibDRUG

200mg every 12 hours

Celecoxib for pain management
TylenolDRUG

650mg q6h

Celecoxib for pain managementPlacebo for pain management
OxycodoneDRUG

5mg every 6 hours as needed

Celecoxib for pain managementPlacebo for pain management
placeboDRUG

every 12 hours

Placebo for pain management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to understand and the willingness to sign a written informed consent document
  • Willing to comply with all study procedures and be available for the duration of the study
  • Ability to take oral medication
  • Undergoing superficial parotidectomy
  • Individuals at least 18 years of age
  • Adequate organ function as indicated by standard laboratory tests: hematology (complete blood count), clinical chemistry

You may not qualify if:

  • History of NSAIDs contraindication (severe congestive heart failure, CABG within 14 days, arrhythmias, significant coronary artery disease, cardiomyopathy, severe hepatic impairment, history of peptic ulcer disease or GI bleeding, use of anticoagulation (other than prophylactic aspirin)
  • History of uncontrolled hypertension, cerebrovascular accident, sulfa allergy, allergy to celecoxib
  • Concurrent use of CYP2C9 potentiator/inhibitor
  • Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
  • Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
  • Not suitable for study participation due to other reasons at the discretion of the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53702, United States

RECRUITING

MeSH Terms

Interventions

CelecoxibAcetaminophenOxycodone

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAniline CompoundsAminesCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Tiffany Glazer, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Mann, MD

CONTACT

480-272-4258hmann3@wisc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 17, 2024

Study Start

February 28, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)