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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Celecoxib

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celecoxib	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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
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
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)
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)
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)
Withdrawal Due to Lack of Efficacy	The number of subjects who withdrew due to insufficient clinical response was evaluated.	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.	8 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 11, 2009
• First Posted (Estimate): September 14, 2009

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: posttraumatic pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: A3191357