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Completed

NCT Number: NCT00402987

Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

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.

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Key information

Conditions

Pharyngitis Acute Pain Infections Neurologic Manifestations Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Stomatognathic Diseases

Age range

18 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Connecticut Student Health Services

Storrs, Connecticut, 06269-2011, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Celecoxib

Drug

dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg

Placebo

Drug

dose 1 placebo followed 6-12 hours later by dose 2 placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sore Throat Pain Intensity Difference (PID) Within 6 Hours Post-First Dose

    Time frame: Within First 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.

  2. Sore Throat Pain Intensity Difference (PID) From 7 to 24 Hours Post-First Dose

    Time frame: 7 to 24 hours

    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.

  3. Sum of Sore Throat Pain Intensity Difference (SPID) Within 6 Hours Post-First Dose

    Time frame: up to 6 hours

    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.

  4. Sum of Sore Throat Pain Intensity Difference (SPID) From 7 to 24 Hours Post-First Dose

    Time frame: 7 to 24 hours

    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.

  5. Sore Throat Relief Rating Scale (STRRS) Within 6 Hours Post-First Dose

    Time frame: within the first 6 hours

    STRRS score (scale: 0 no relief to 6 complete relief); a higher pain score indicated a greater reduction in pain.

  6. Sore Throat Relief Rating Scale (STRRS) From 7 to 24 Hours Post-First Dose

    Time frame: 7 to 24 hours

    STRRS score (scale: 0 no relief to 6 complete relief); a higher score indicated a greater reduction in pain.

  7. Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 6 Hours Post-First Dose

    Time frame: at 6 hours

    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).

  8. Sore Throat Relief Rating Scale (STRRS) - 'Moderate Relief' at 12 Hours Post-First Dose

    Time frame: 12 hours

    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).

  9. Time to Perceptible Pain Relief

    Time frame: Within 2 Hours Post-First Dose

    Defined as time (measured by stopwatch) when subject began to feel any pain relieving effect from the drug

  10. Time to Meaningful Pain Relief

    Time frame: Within 2 Hours Post-First Dose

    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

  11. Time to Onset of Analgesia

    Time frame: Within 2 Hours Post-First Dose

    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

  12. Patient's Global Evaluation of Study Medication at 6 Hours Post-First Dose

    Time frame: 6 Hours Post-First Dose

    Subject assessment of overall impression of study drug on 4 point scale from 1 (poor) to 4 (excellent)

  13. Patient's Global Evaluation of Study Medication at 12 and 24 Hours Post-First Dose

    Time frame: 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)

Other outcomes

  1. Throat Soreness Scale (TSS) Difference Within 6 Hours Post-First Dose

    Time frame: Within first 6 hours post-first dose

    The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.

  2. Throat Soreness Scale (TSS) Difference From 7 to 24 Hours Post-First Dose

    Time frame: 7 to 24 hours post-first dose

    The Pain Intensity Difference (PID) based on TSS (scale: 0=not sore to 10=very sore) was calculated as the difference between the pain intensity at the time and at baseline.

  3. Sore Throat Pain Intensity Difference (SPID2) as Measured by Throat Soreness Scale (TSS) at 2 Hours Post-First Dose

    Time frame: 2 hour period Post-First Dose

    SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS scale: 0=not sore to 10=very sore) at 2 hours post dose and at baseline.

  4. Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) Within 6 Hours Post-First Dose

    Time frame: Within 6 hours Post-First Dose

    The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.

  5. Sum of Throat Soreness Difference as Measured by Throat Soreness Scale (TSS) From 7 to 24 Hours Post-First Dose

    Time frame: 7 to 24 hours Post-First Dose

    The sum of sore throat pain intensity differences (SPID) was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Sore Throat PID was calculated as the difference between the pain intensity (TSS range: 0=not sore to 10=very sore) at the time and at baseline.

  6. Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose

    Time frame: Within 6 hours Post-First Dose

    The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

  7. Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose

    Time frame: 7 to 24 hours Post-First Dose

    The Difficulty Swallowing Pain Intensity Difference (PID) was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

  8. Sum of Sore Throat Pain Intensity Difference (SPID2) as Measured by Difficulty Swallowing Scale (DSS) at 2 Hours Post-First Dose

    Time frame: Over 2 hour Period Post-First Dose

    SPID2 was calculated as the AUC of the Pain Intensity Difference (PID) scores. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 2 hours post dose and at baseline.

  9. Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) Within 6 Hours Post-First Dose

    Time frame: 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 Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

  10. Sum of Difficulty Swallowing Difference as Measured by Difficulty Swallowing Scale (DSS) From 7 to 24 Hours Post-First Dose

    Time frame: 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 Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS range: 0mm=not difficult, 100mm=very difficult) at the time and at baseline.

  11. Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 6 Hours Post-First Dose

    Time frame: At 6 hours

    Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 6 hours and at baseline.

  12. Difficulty Swallowing Scale (DSS) Difference at Least 50% Gone at 12 Hours Post-First Dose

    Time frame: At 12 Hours

    Number of Subjects with >= 50% Pain Intensity Difference (PID) on the DSS. The Difficulty Swallowing PID was calculated as the difference between the pain intensity (DSS scale: 0mm=not difficult, 100mm=very difficult) at 12 hours and at baseline.

  13. Total Pain Relief (TOTPAR) at 2 and 6 Hours Post-First Dose

    Time frame: 2 and 6 hours Post-First Dose

    TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).

  14. Total Pain Relief (TOTPAR) at 12 and 24 Hours Post-First Dose

    Time frame: 12 and 24 hours Post-First Dose

    TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief).

  15. Subjects With >= 50% Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose

    Time frame: 6 hours Post-First Dose

    TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 6 hours is 36. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.

  16. Subjects With >= 50% Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose

    Time frame: 12 hours Post-First Dose

    TOTPAR is time-interval-weighted sum of accumulated Sore Throat Relief Rating Scale (STRRS) scores (scale: 0 no relief to 6 complete relief). Maximum TOTPAR over 12 hours is 72. If the subject calculated TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject is said to have achieved >=50% TOTPAR.

  17. Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 6 Hours Post-First Dose

    Time frame: 6 hours Post-First Dose

    NNT is number of subjects needed to treat to have one extra subject report a 50% or better pain relief over 6 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 6 hours is 36. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.

  18. Number Needed to Treat (NNT) to Achieve at Least 50% of Maximum Total Pain Relief (TOTPAR) at 12 Hours Post-First Dose

    Time frame: 12 hours Post-First Dose

    NNT is number of subjects needed to treat to have one subject report a 50% or better pain relief over 12 hours based on maximum possible pain relief on Sore Throat Relief Rating Scale. Maximum TOTPAR over 12 hours is 72. If the subject TOTPAR is greater than or equal to 50% of the maximum TOTPAR then the subject has achieved >=50% TOTPAR.

  19. Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 2 and 6 Hours Post-First Dose

    Time frame: 2 and 6 hours Post-First Dose

    >= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at the time and at baseline.

  20. Subjects With Sore Throat Pain at Least 35% Gone and at Least 50% Gone at 12 Hours Post-First Dose

    Time frame: 12 hours Post-First Dose

    >= 35% and 50% Pain Intensity Difference (PID) on the Pain Intensity-Visual Analog Scale (PI-VAS) (scale: 0mm=no pain, 100mm=worst possible pain). The PID was calculated as the difference between the pain intensity at 12 hours and at baseline.

  21. Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 2 and 6 Hours Post-First Dose

    Time frame: 2 and 6 hours Post-First Dose

    Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.

  22. Subjects Who Achieved Their Own Level of 'Meaningful Relief' and 'Much Improvement' at 12 Hours Post-First Dose

    Time frame: 12 hours Post-First Dose

    Symptom relief measured as self-directed endpoints defined by each individual at end of study using Sore Throat Relief Rating Scale (STRRS); STRRS score ranges from 0=no relief to 6=complete relief. If subject scored same or greater in their STRRS during the study then they achieved their 'Meaningful Relief' or 'Much Improvement'.

  23. Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Had Perceptible Relief Onset Time Within 1 Hour

    Time frame: Within 6 hours Post-First Dose

    At end of study subjects defined meaningful pain relief by completing Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS) score (range: 0=no relief to 6=complete relief) at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0.

  24. Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Who Still Had Perceptible Relief at 12 and 24 Hours Post-First Dose

    Time frame: 12 and 24 hours Post-First Dose

    At end of study subjects defined meaningful pain relief by completing the Meaningful Relief Scale. Meaningful relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief) score at end of the study was the same or higher than individually defined relief score during the study. Perceptible relief is STRRS >0

  25. Median Onset Time of First Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose

    Time frame: 24 Hours

    Perceptible Relief is score >0 on STRRS. Individual level of meaningful relief had to be reached within 6 hours. Meaningful Relief was achieved if Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief)score at the end of the study was the same or higher than individually defined meaningful relief score during the study.

  26. Median Offset Time of No Perceptible Relief in Subjects Who Achieved Their Own Level of 'Meaningful Relief' Within 6 Hours Post-First Dose

    Time frame: 24 Hours

    Offset time is time of first no perceptible relief (STRRS score=0) with meaningful relief (score>0) at earlier time. STRRS score ranges from 0=no relief to 6=complete relief.

  27. Treatment Failures on STRRS Questionnaire

    Time frame: 24 hours Post-First Dose

    Subjects were considered treatment failures if all of the STRRS scores were less than each individual's 'meaningful relief' scores. STRRS score ranges from 0=no relief to 6=complete relief.

  28. Subjects Taking Rescue Medication

    Time frame: Within 24 hours Post-First Dose

    Subjects were allowed to use rescue medication at any time during the trial, but were discouraged from taking rescue medication within 2 hours of administration of the first dose of study drug.

  29. Treatment Satisfaction Questionnaire for Medication (TSQM vII)

    Time frame: 24 hours or immediately prior to taking rescue medication

    11 questions scored on factors: effectiveness, side effects, convenience, overall satisfaction. TSQM vII scores range 0 to 100, with higher scores indicating a higher level of global satisfaction with treatment.

  30. First Perceptible Relief

    Time frame: up to 24 hours

    Subjects having First Perceptible Relief at each time point. Perceptible relief is score >0 on Sore Throat Relief Rating Scale(STRRS)(range: 0=no relief to 6=complete relief).

  31. No Perceptible Relief

    Time frame: up to 24 hours

    Subjects having No Perceptible Relief at each time point. No Perceptible relief is score = 0 on Sore Throat Relief Rating Scale (STRRS)(range: 0=no relief to 6=complete relief).

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 23, 2006
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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