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Completed

NCT Number: NCT00976716

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Funabashi, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Withdrawal Due to Lack of Efficacy

    Time frame: 8 days

    The number of subjects who withdrew due to insufficient clinical response was evaluated.

  12. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2009
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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