PharyngitisPhase 3NCT00647829
A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat
A Phase 3 study testing valdecoxib in people with Pharyngitis, run by Pfizer at 2 sites in United States.
Trial summary
The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngitis
- What is being tested?
- valdecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Dec 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.
Who cannot join
- Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
Boca Raton, Florida, 33433
Pfizer Investigational Site
Storrs, Connecticut, 06269-2011
About this study
Official title: Clinical Protocol For A Double-Blind, Randomized, Placebo-Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Bextra® (Valdecoxib) 20 Mg Twice Daily, Bextra® 40 Mg Once Daily, And Placebo In The Symptomatic Treatment Of Subjects With Pharyngitis
The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. In addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. The study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.
- Conditions
- Pharyngitis
- Being tested
- valdecoxib, placebo
- Keywords
- pharyngitis, sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valdecoxibDrug
valdecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period
valdecoxibDrug
valdecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period
placeboDrug
placebo tablet by mouth for 2 doses over a 24-hour period
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 3 | 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 (SPID, VAS) on swallowing
Measured: 2-hour period after the first dose
Secondary outcomes (16)
Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
Measured: 4, 6, 8, 10, 12, and 24 hours after first dose
Peak Sore Throat Pain Intensity Difference (PPID) on swallowing
Measured: 24-hour period after the first dose
Throat Soreness Difference (TSD) on swallowing
Measured: each post dose time point
Sum of Throat Soreness Difference (STSD) on swallowing
Measured: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
Peak Throat Soreness Difference (PTSD) on swallowing
Measured: 24-hour period after the first dose
Sum of Sore Throat Relief Rating (SSTRR) on swallowing
Measured: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
Peak Sore Throat Relief Rating (PSTRR) on swallowing
Measured: 24-hour period after the first dose
Time to onset of analgesia
Measured: 2-hour period after the first dose
Time to rescue medication
Measured: 24-hour period after the first dose
Patient's global evaluation of study medication
Measured: 24-hour period after the first dose
Percent of patients taking rescue medications
Measured: 24-hour period after the first dose
Sore Throat Relief Rating (STRR) on swallowing
Measured: post dose time point
Patient's satisfaction with treatment
Measured: 24-hour period after the first dose
Sore Throat Pain Intensity Difference (PID, VAS) on swallowing
Measured: each post dose time point
Time to perceptible pain relief
Measured: 2-hour period after the first dose
Time to meaningful pain relief
Measured: 2-hour period after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startFeb 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647829
- Sponsor's protocol ID
- A3471026
- Status last verified
- Apr 2008
- First submitted
- 27 Mar 2008
- Last updated
- 24 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol For A Double-Blind, Randomized, Placebo-Controlled Comparison Of The Efficacy, Safety, And Tolerability Of Bextra® (Valdecoxib) 20 Mg Twice Daily, Bextra® 40 Mg Once Daily, And Placebo In The Symptomatic Treatment Of Subjects With Pharyngitis
- ClinicalTrials.gov ID
- NCT00647829
- Acronym / sponsor ID
- A3471026
- Conditions
- Pharyngitis
- Keywords
- pharyngitis, sore throat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Dec 2003 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was performed to evaluate the analgesic efficacy, safety, and tolerability of valdecoxib 20 mg twice daily (BID), valdecoxib 40 mg once daily (QD), and placebo in patients with moderately to severely painful symptomatic sore throat over a 24-hour period. In addition, the study was to validate a new scale and criteria for measuring pain in sore throat and evaluate the effects of selective serotonin reuptake inhibitors and past sore throat pain on pain score and efficacy of analgesics. The study also examined what type of medications are commonly used for sore throat and whether this information has relevance to analgesic efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: valdecoxib |
| Arm 2 | Active comparator | Drug: valdecoxib |
| Arm 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Included patients had moderate to severe pain, as measured by the Sore Throat Pain Intensity Scale (STPIS) on swallowing ≥66 mm on a 100-mm visual analogue scale (VAS) and a minimum of 4 points on the 10-point Tonsillo-Pharyngitis Score (TPS) but who were not coughing or experiencing any evidence of mouth-breathing.
Key exclusion criteria (1 listed)
- Patients who used throat lozenges, throat spray, cough drops or menthol-containing products within 2 hours, short-acting analgesics/antipyretics (eg, ibuprofen) or any form of cold medication within 8 hours, antibiotics for acute disease within 24 hours of first dose of study medication, or presumed diagnosis of infectious mononucleosis, known allergy or hypersensitivity to NSAIDs, COX-2 specific inhibitors, sulfonamides, or acetaminophen were excluded.
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 |
|---|---|---|
| valdecoxibvaldecoxib 20 mg tablet by mouth twice daily (BID) for 2 doses over a 24-hour period | Drug | Arm 1 |
| valdecoxibvaldecoxib 40 mg tablet by mouth once daily (QD) for 2 doses over a 24-hour period | Drug | Arm 2 |
| placeboplacebo tablet by mouth for 2 doses over a 24-hour period | Drug | Arm 3 |
Primary outcome
Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
Time frame: 2-hour period after the first dose
16 secondary outcomes
Sum of Sore Throat Pain Intensity Difference (SPID, VAS) on swallowing
Time frame: 4, 6, 8, 10, 12, and 24 hours after first dose
Peak Sore Throat Pain Intensity Difference (PPID) on swallowing
Time frame: 24-hour period after the first dose
Throat Soreness Difference (TSD) on swallowing
Time frame: each post dose time point
Sum of Throat Soreness Difference (STSD) on swallowing
Time frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
Peak Throat Soreness Difference (PTSD) on swallowing
Time frame: 24-hour period after the first dose
Sum of Sore Throat Relief Rating (SSTRR) on swallowing
Time frame: 2, 4, 6, 8, 10, 12, and 24 hours after first dose
Peak Sore Throat Relief Rating (PSTRR) on swallowing
Time frame: 24-hour period after the first dose
Time to onset of analgesia
Time frame: 2-hour period after the first dose
Time to rescue medication
Time frame: 24-hour period after the first dose
Patient's global evaluation of study medication
Time frame: 24-hour period after the first dose
Percent of patients taking rescue medications
Time frame: 24-hour period after the first dose
Sore Throat Relief Rating (STRR) on swallowing
Time frame: post dose time point
Patient's satisfaction with treatment
Time frame: 24-hour period after the first dose
Sore Throat Pain Intensity Difference (PID, VAS) on swallowing
Time frame: each post dose time point
Time to perceptible pain relief
Time frame: 2-hour period after the first dose
Time to meaningful pain relief
Time frame: 2-hour period after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing valdecoxib in people with Pharyngitis, run by Pfizer at 2 sites 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 1 inclusion and 1 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 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (SPID, VAS) on swallowing (time frame: 2-hour period after the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2008.