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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976716
• Other study ID #: A3191357
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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"

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Celecoxib
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

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Ageo	Saitama
Japan	Pfizer Investigational Site	Edogawaku	Tokyo
Japan	Pfizer Investigational Site	Funabashi	Chiba
Japan	Pfizer Investigational Site	Ichikawa	Chiba
Japan	Pfizer Investigational Site	Kofu	Yamanashi
Japan	Pfizer Investigational Site	Kotoku	Tokyo
Japan	Pfizer Investigational Site	Matsudo	Chiba
Japan	Pfizer Investigational Site	Nerimaku	Tokyo
Japan	Pfizer Investigational Site	Sagamihara	Kanagawa
Japan	Pfizer Investigational Site	Saitama-shi	Saitama
Japan	Pfizer Investigational Site	Toshimaku	Tokyo

Sponsors (1)

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

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 days
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	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	6 hours
Secondary	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.	Two, 4 and 6 hours post first dose
Secondary	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.	Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Secondary	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.	Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Secondary	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.	Baseline, Days 4 (Visit 2) and 8 (Visit 3)
Secondary	Withdrawal Due to Lack of Efficacy	The number of subjects who withdrew due to insufficient clinical response was evaluated.	8 days
Secondary	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.	8 days

External Links

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