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Celecoxib for Chronic Rhinosinusitis
Phase 4
Recruiting
Led By Leigh Sowerby, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CRS with nasal polyposis in the setting of AERD, and requiring FESS for management after failing medical management per the Canadian clinical practice guidelines for acute and chronic sinusitis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.
Awards & highlights
Study Summary
This trial will test if celecoxib can help improve surgical outcomes and reduce postoperative pain for people with aspirin-exacerbated respiratory disease and Chronic rhinosinusitis following endoscopic sinus surgery.
Who is the study for?
This trial is for adults over 18 with chronic rhinosinusitis and nasal polyps, specifically in the context of aspirin-exacerbated respiratory disease (AERD), who need surgery after other treatments haven't worked. Participants must be able to understand English and give informed consent. Exclusions include pregnant or breastfeeding women, those with certain heart, kidney, liver conditions, bleeding disorders, drug abuse history or taking conflicting medications.Check my eligibility
What is being tested?
The study tests whether Celecoxib, a COX-2 inhibitor painkiller can reduce inflammation and pain better than a placebo after sinus surgery in AERD patients. It's randomized which means participants are put into the Celecoxib or placebo group by chance.See study design
What are the potential side effects?
Celecoxib may cause stomach ulcers or bleeding, worsen heart failure or kidney problems if pre-existing conditions are present. It might also interact with other drugs affecting blood clotting and blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe sinusitis with nasal polyps and asthma, needing surgery after other treatments failed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6h after surgery; 24 hours after surgery; 7 days post-surgery (daily); at the 14th day; and at the 21st day.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post FESS changes in the Lund-Kennedy Endoscopic Score (LKES)
Post FESS changes in the Peri-Operative Sinus Endoscopy (POSE) score
Post FESS changes in the validated Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire
Secondary outcome measures
Post FESS changes in the pain level assessed via the 10-point visual analogue scale
Other outcome measures
Amount of analgesic medication taken on postoperative days 0-7, self reported by the patients.
Compliance with prescribed nasal saline rinses, self reported by the patients.
Number of epistaxis events, self reported by the patients.
+1 moreSide effects data
From 2010 Phase 2 trial • 255 Patients • NCT010621135%
Beta 2 microglobulin increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Blood bilirubin increased
2%
Eczema
1%
White blood cell count increased
1%
Blood urine present
1%
Hypoaesthesia facial
1%
Rash
1%
Post procedural haemorrhage
1%
Blood creatine phosphokinase increased
1%
Blood phosphorus decreased
1%
Urobilin urine present
1%
Presyncope
1%
Somnolence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Initial Dose Celecoxib 400 mg
Additional Dose Placebo
Additional Dose Celecoxib 200 mg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Celecoxib GroupExperimental Treatment1 Intervention
Patients will receive the interventional drug for 7 days post endoscopic sinus surgery. These patients will also receive a prescription for tramadol (50 mg PO Q6H PRN x 10 tablets), to be used as needed for breakthrough pain. Patients will also be permitted to take acetaminophen for breakthrough pain as needed and will be encouraged to use acetaminophen prior to narcotic usage. Finally, they will be prescribed a nasal saline rinse, which is to be started on postoperative day one.
Group II: Control GroupPlacebo Group1 Intervention
Patients will receive the placebo for 7 days post endoscopic sinus surgery. These patients will also receive a prescription for tramadol (50 mg PO Q6H PRN x 10 tablets), to be used as needed for breakthrough pain. Patients will also be permitted to take acetaminophen for breakthrough pain as needed and will be encouraged to use acetaminophen prior to narcotic usage. Finally, they will be prescribed a nasal saline rinse, which is to be started on postoperative day one.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2019
Completed Phase 4
~1740
Find a Location
Who is running the clinical trial?
Western University, CanadaOTHER
239 Previous Clinical Trials
57,439 Total Patients Enrolled
London Health Sciences CentreOTHER
142 Previous Clinical Trials
49,874 Total Patients Enrolled
University of Western Ontario, CanadaOTHER
164 Previous Clinical Trials
319,202 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications like blood thinners, blood pressure pills, water pills, lithium, cidofovir, carbamazepine, or antidepressants.I have a blood clotting disorder.I have severe sinusitis with nasal polyps and asthma, needing surgery after other treatments failed.I am 18 years old or older.I understand the study and agree to participate.I have been diagnosed with ischemic heart disease.I have been diagnosed with mild to moderate heart failure.I am not taking medications that affect serotonin levels.I am allergic to acetaminophen, opioids, or certain anti-inflammatory drugs.You have a history of misusing or becoming addicted to opioid drugs.I have had stomach ulcers or bleeding.I am not pregnant or breastfeeding.I have kidney or liver problems.I have been diagnosed with inflammatory bowel disease.I have chronic pain or I use opioids regularly.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Celecoxib Group
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Celecoxib received regulatory approval from the FDA?
"Celebrated drug Celecoxib, having gone through a Phase 4 trial and been approved by the regulatory agency, got an impressive rating of 3."
Answered by AI
How many participants are being accepted into this medical study?
"Affirmative. According to information hosted on clinicaltrials.gov, 44 people are being sought for this medical research project that was first posted in February 18th 2020 and most recently updated in April 5th 2022. One site is currently participating in the study's recruitment process."
Answered by AI
In what ways is Celecoxib traditionally deployed to benefit patients?
"Celecoxib can be utilized to alleviate symptoms of pain, primary dysmenorrhoea, and rheumatoid arthritis."
Answered by AI
Is this clinical trial accepting additional participants?
"Affirmative. Clinicaltrials.gov states that this medical trial, which was first launched on February 18th 2020, is still actively recruiting participants. A total of 44 patients are needed to be enrolled from a single site."
Answered by AI
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