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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2009

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Celecoxib

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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)
    • 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.
  • 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)
    • 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.
  • 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)
    • 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.
  • 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)
    • 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.
  • 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)
    • 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.
  • 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
    • 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
  • 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
    • 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.
  • Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
    • Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
    • 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.
  • Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
    • Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
    • 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.
  • Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
    • Time Frame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
    • 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.
  • Withdrawal Due to Lack of Efficacy
    • Time Frame: 8 days
    • The number of subjects who withdrew due to insufficient clinical response was evaluated.
  • Summary of Adverse Events
    • Time Frame: 8 days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer’s Upjohn has merged with Mylan to form Viatris Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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