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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00976716
First received: September 11, 2009
Last updated: April 25, 2011
Last verified: April 2011

September 11, 2009
April 25, 2011
September 2009
November 2009   (final data collection date for primary outcome measure)
Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") [ Time Frame: 8 days ] [ Designated as safety issue: No ]

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.

Patient Impressions (the proportion of subjects who have rated "worked well" and "worked") [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00976716 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of subjects who withdrew due to insufficient clinical response was evaluated.
  • Summary of Adverse Events [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    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.
  • Pain intensity (VAS:Visual Analog Scale) of pain at rest (spontaneous pain) and active movement pain [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Pain intensity differences in pain at rest (spontaneous pain) and active movement pain [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Sum of pain intensity differences in pain at rest (spontaneous pain) and active movement pain until 6 hours after the first dose of study drug [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Peak pain intensity difference in pain at rest (spontaneous pain) and active movement pain until 6 hours after the first dose of study drug [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Severity of inflammatory symptoms (each of swelling, redness, and local burn) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Patient Impressions (the proportion of subjects who have rated "worked well" and "worked") [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • The assessment of safety [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
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

Other Name: Not specified
Experimental: Celecoxib
Intervention: Drug: Celecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00976716
A3191357
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP