PainPhase 3NCT00976716

An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain

A Phase 3 study testing Celecoxib in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 11 sites in Japan.

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

To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Pain
What is being tested?: Celecoxib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 11 sitesJapan
Study dates: Sep 2009to Nov 2009
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with posttraumatic pain which is able to be controlled with an oral NSAID
Patients with "pain" that meets both of the following criteria within 48 hours after injury:
"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more
Patients with "inflammation" that meets the following criteria within 48 hours after injury.
"Inflammation" Categorical: "Mild", "Moderate" or "Severe"

Who cannot join

Patients who have received analgesics and anaesthetics for injury
Patients with a history/complication of aspirin-induced asthma
Patients taking excluded medications
Patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Japan11 sites

Pfizer Investigational Site
Ageo, Saitama
Pfizer Investigational Site
Edogawaku, Tokyo
Pfizer Investigational Site
Funabashi, Chiba
Pfizer Investigational Site
Ichikawa, Chiba
Pfizer Investigational Site
Kofu, Yamanashi
Pfizer Investigational Site
Kotoku, Tokyo
Pfizer Investigational Site
Matsudo, Chiba
Pfizer Investigational Site
Nerimaku, Tokyo
Pfizer Investigational Site
Sagamihara, Kanagawa
Pfizer Investigational Site
Saitama-shi, Saitama
Pfizer Investigational Site
Toshimaku, Tokyo

Other trials in Japan

About this study

Official title: An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain

To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.

Conditions: Pain
Being tested: Celecoxib
Keywords: posttraumatic pain
Medical subject headings: Pain

What participants receive

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

CelecoxibDrug
Day 1
- The first dose: Celecoxib 400mg
- The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed
Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8)
- Celecoxib 200mg twice daily

Study groups in NCT00976716
Study group	Role	What they receive
Celecoxib	Experimental	Not described Receives: Drug: Celecoxib

What is being measured

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

Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good")
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor."
Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit.
Measured: 8 days

Secondary outcomes (12)

Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor."
Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until each time point.
Measured: 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
The PI of pain at rest (spontaneous pain) was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
Measured: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
The PI of pain on active movement was recorded on the 100 mm VAS in the patient diary, where 0 mm=no pain, 100 mm=worst possible pain.
Measured: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
The PID score was obtained by subtracting the PI (by VAS: 0 mm=no pain, 100 mm=worst possible pain) at each time point from the Baseline PI score. Increase in PID scores indicated a lessening of subjects' pain compared to baseline scores; higher scores indicated a greater reduction in pain.
Measured: Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
PID in Pain on Active Movement Within 8 Days Post-first Dose
The 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: 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
The SPID was derived according to the following rule: each PID was weighted by the width of time interval between previous and current time points in hours and summed up to 6 hours post-first dose
Measured: 6 hours
Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
The PPID was obtained by subtracting the maximum value of pain intensity (PI) at a time point among 2 to 6 hours post first dose from baseline value of PI for each patient.
Measured: Two, 4 and 6 hours post first dose
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
The investigator assessed the swelling, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Measured: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
The investigator assessed the redness, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Measured: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
The investigator assessed the localized warmth, using the categories "None," "Mild," "Moderate," and "Severe" at Baseline, Visit 2 (Day 4), Visit 3 (Day 8) and Final Visit.
Measured: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Withdrawal Due to Lack of Efficacy
The number of subjects who withdrew due to insufficient clinical response was evaluated.
Measured: 8 days
Summary of Adverse Events
The number of subjects who experienced adverse events (AEs; all-causality and treatment-related) based on safety assessment was summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Measured: 8 days

Timeline

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

Sep 2009Nov 2009

First posted14 Sep 2009 (estimated)
Study startSep 2009
Primary completionNov 2009
Study completionNov 2009

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 PainStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00976716
Sponsor's protocol ID: A3191357
Status last verified: Jan 2021
First submitted: 11 Sep 2009
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain
ClinicalTrials.gov ID: NCT00976716
Acronym / sponsor ID: A3191357
Conditions: Pain
Keywords: posttraumatic pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 14 Sep 2009 (estimated)
Results: Posted 19 May 2011

Clinical summary

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

To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Celecoxib	Experimental	Drug: Celecoxib

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with posttraumatic pain which is able to be controlled with an oral NSAID
Patients with "pain" that meets both of the following criteria within 48 hours after injury:
"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more
Patients with "inflammation" that meets the following criteria within 48 hours after injury.
"Inflammation" Categorical: "Mild", "Moderate" or "Severe"

Key exclusion criteria (4 listed)

Patients who have received analgesics and anaesthetics for injury
Patients with a history/complication of aspirin-induced asthma
Patients taking excluded medications
Patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization

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
CelecoxibDay 1 * The first dose: Celecoxib 400mg * The second dose: Celecoxib 200mg during a period between 6 hours post-first dose and before bed Days 2 to 8 (Study drug should be taken until the dose scheduled after breakfast on the day of Day 8) - Celecoxib 200mg twice daily	Drug	Celecoxib

Primary outcome

Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good")
Time frame: 8 days
The patient impression of the study medication was entered in the patient diary based on the following categories: "excellent," "good," "fair" and "poor." Efficacy was based on the patient impression of the study medication ("excellent" and "good") from the first study medication until Final Visit.

12 secondary outcomes

Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
Time frame: 6 hours post first dose and before sleep on Day 1, before sleep on Day 2, Day 4 (Visit 2) and Day 8 (Visit 3)
Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
Time frame: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
Time frame: Baseline, 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
Time frame: Two, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
PID in Pain on Active Movement Within 8 Days Post-first Dose
Time frame: 2, 4 and 6 hours post first dose, and before sleep on Day 1, on awakening and before sleep on Days 2 to 7, on awakening on Day 8 and Visit 3 (Day 8)
Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Time frame: 6 hours
Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
Time frame: Two, 4 and 6 hours post first dose
Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
Time frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
Time frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
Time frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Withdrawal Due to Lack of Efficacy
Time frame: 8 days
Summary of Adverse Events
Time frame: 8 days

Results and safety

Results posted to the registry on 19 May 2011, 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	80	79

Primary outcome: Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good")

Time frame: 8 days. Number. Unit: Participants

Measure	Celecoxib n = 80
Value	70

Population analysed: The full analysis set (FAS) consisted of all patients who received at least one study medication and had at least one post-baseline efficacy endpoint measurement regardless of the primary or secondary endpoints. For the summary at Final Visit, the method of the last observation carried forward (LOCF) was used.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	0 of 80 (0%)	10 of 80 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.

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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

11 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 Celecoxib in people with Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 11 sites in Japan.

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 5 inclusion and 4 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. 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. 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 19 May 2011). 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?

Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") (time frame: 8 days). 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 NCT00976716.

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 2 Feb 2021.