PharyngitisPhase 3NCT00402987

Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

A Phase 3 study testing Celecoxib in people with Pharyngitis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions. Read more about this study

Who is it for?: Ages 18 to 18 years
Conditions the study is for: Pharyngitis
What is being tested?: Celecoxib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 269 participants
Where: 1 siteUnited States
Study dates: 4 Dec 2006to 15 Nov 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 18 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis.
The patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat.

Who cannot join

The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication.
The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Connecticut Student Health Services
Storrs, Connecticut, 06269-2011

Other trials in United States

About this study

Official title: A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED COMPARISON OF THE EFFICACY, SAFETY, AND TOLERABILITY OF CELECOXIB 100-150 MG, INCLUDING INITIAL DOSES OF 50 AND 100 MG, AND PLACEBO IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH PAINFUL PHARYNGITIS

Conditions: Pharyngitis
Being tested: Celecoxib, placebo
Keywords: sore throat, acute pain
Medical subject headings: Pharyngitis, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
CelecoxibDrug
dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
celecoxibDrug
dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
placeboDrug
dose 1 placebo followed 6-12 hours later by dose 2 placebo

Study groups in NCT00402987
Study group	Role	What they receive
celecoxib 50 mg/50 mg	Experimental	Not described Receives: Drug: Celecoxib
celecoxib 100 mg/placebo	Experimental	Not described Receives: Drug: Celecoxib
celecoxib 100 mg/50 mg	Experimental	Not described Receives: Drug: celecoxib
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose
Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.
Measured: 2 hours Post-First Dose

Secondary outcomes (13)

Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. Sore throat PID score was obtained by subtracting the PI at each time point from the Baseline PI score. Increase in scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Measured: Within First 6 hours Post-First Dose
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose
Pain intensity (PI) on Swallowing as Measured by PI-VAS scale: 0mm=no pain, 100mm=worst possible pain. PID score was obtained by subtracting the PI at each time point from the Baseline PI score. An increase in scores indicated a lessening of subjects' pain as compared to Baseline scores, thus, higher scores indicated a greater reduction in pain.
Measured: 7 to 24 hours
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose
The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.
Measured: up to 6 hours
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose
The sum of pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The PID [based on PI-VAS scale: 0mm=no pain, 100mm=worst possible pain] was calculated as the difference between the pain intensity at the time and at baseline.
Measured: 7 to 24 hours
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose
STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.
Measured: within the first 6 hours
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose
STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.
Measured: 7 to 24 hours
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose
Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).
Measured: at 6 hours
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose
Subjects Achieving at Least 'Moderate Relief' as Measured by STRRS (range: 0=no relief to 6=complete relief); Moderate relief is defined as STRRS = 3).
Measured: 12 hours
Time to Perceptible Pain Relief
Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug
Measured: Within 2 Hours Post-First Dose
Time to Meaningful Pain Relief
The time (measured by stopwatch) when the subject felt their pain relief was meaningful to them was not estimable thus the number of subjects experiencing meaningful pain relief within 2 hours of first dose is reported
Measured: Within 2 Hours Post-First Dose
Time to Onset of Analgesia
Equal to time of perceptible pain relief when both perceptible pain relief and meaningful pain relief were experienced- the median time was not estimable thus the number of subjects with onset of analgesia within 2 hours of first dose is reported
Measured: Within 2 Hours Post-First Dose
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose
Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)
Measured: 6 Hours Post-First Dose
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose
Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)
Measured: 12 and 24 hours Post-First Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 200615 Nov 2007

First posted23 Nov 2006 (estimated)
Study start4 Dec 2006
Primary completion15 Nov 2007
Study completion15 Nov 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PharyngitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 269 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402987
Sponsor's protocol ID: A3191334
Status last verified: Mar 2021
First submitted: 21 Nov 2006
Last updated: 3 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED COMPARISON OF THE EFFICACY, SAFETY, AND TOLERABILITY OF CELECOXIB 100-150 MG, INCLUDING INITIAL DOSES OF 50 AND 100 MG, AND PLACEBO IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH PAINFUL PHARYNGITIS
ClinicalTrials.gov ID: NCT00402987
Acronym / sponsor ID: A3191334
Conditions: Pharyngitis
Keywords: sore throat, acute pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 269 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: 4 Dec 2006 (actual)
Primary completion: 15 Nov 2007 (actual)
Study completion: 15 Nov 2007 (actual)
First posted: 23 Nov 2006 (estimated)
Results: Posted 12 Mar 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
celecoxib 50 mg/50 mg	Experimental	Drug: Celecoxib
celecoxib 100 mg/placebo	Experimental	Drug: Celecoxib
celecoxib 100 mg/50 mg	Experimental	Drug: celecoxib
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis.
The patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat.

Key exclusion criteria (2 listed)

The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication.
The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Celecoxibdose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Drug	celecoxib 50 mg/50 mg
Celecoxibdose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo	Drug	celecoxib 100 mg/placebo
celecoxibdose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg	Drug	celecoxib 100 mg/50 mg
placebodose 1 placebo followed 6-12 hours later by dose 2 placebo	Drug	Placebo

Primary outcome

Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose
Time frame: 2 hours Post-First Dose
Based on the Pain Intensity scores measured on a Visual Analogue Scale (PI-VAS: 0mm=no pain,100mm=worst possible pain), assessed by the subjects, the SPID2 is the area under the curve (AUC) over the 2-hour period post-first dose of the Pain Intensity Difference (PID) scores using the trapezoidal rule.

13 secondary outcomes

Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose
Time frame: Within First 6 hours Post-First Dose
Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose
Time frame: 7 to 24 hours
Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose
Time frame: up to 6 hours
Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose
Time frame: 7 to 24 hours
Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose
Time frame: within the first 6 hours
Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose
Time frame: 7 to 24 hours
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose
Time frame: at 6 hours
Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose
Time frame: 12 hours
Time to Perceptible Pain Relief
Time frame: Within 2 Hours Post-First Dose
Time to Meaningful Pain Relief
Time frame: Within 2 Hours Post-First Dose
Time to Onset of Analgesia
Time frame: Within 2 Hours Post-First Dose
Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose
Time frame: 6 Hours Post-First Dose
Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose
Time frame: 12 and 24 hours Post-First Dose

Results and safety

Results posted to the registry on 12 Mar 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib 50mg/50mg	90	90
Celecoxib 100mg/Placebo	45	45
Celecoxib 100mg/50mg	45	44
Placebo	89	89

Primary outcome: Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose

Time frame: 2 hours Post-First Dose. Least squares mean (Standard Error). Unit: units on a scale * hours

Measure	Celecoxib 100mg (Pooled) n = 90	Placebo n = 89
Value	21.0 (2.20)	9.4 (2.21)

Celecoxib 100mg (Pooled) vs Placebo: Mean Difference (Final Values): 11.7 (95% CI 5.5 to 17.9), p = 0.0003, generalized linear model

Population analysed: Modified intent-to-treat (MITT) population, defined as all subjects randomized to treatment who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. The celecoxib 100mg (pooled) treatment group and placebo were compared for the primary endpoint. Celecoxib 50mg/50mg group was not in this analysis.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (Day 1) up to 28 days after last dose of study drug ( up to a maximum of 30 days). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib 50mg/50mg	0 of 90 (0%)	8 of 90 (8.9%)	0 of 90
Celecoxib 100mg/Placebo	0 of 45 (0%)	5 of 45 (11.1%)	0 of 45
Celecoxib 100mg/50mg	0 of 45 (0%)	5 of 45 (11.1%)	0 of 45
Placebo	0 of 89 (0%)	6 of 89 (6.7%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Celecoxib in people with Pharyngitis, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of Sore Throat Pain Intensity Difference (SPID2) on Swallowing at 2 Hours Post-First Dose (time frame: 2 hours Post-First Dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.