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

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ClinicalTrials.gov Identifier: NCT00976716
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : May 19, 2011
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Results First Submitted Date  ICMJE October 25, 2010
Results First Posted Date  ICMJE May 19, 2011
Last Update Posted Date May 19, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Patient Impressions (the proportion of subjects who have rated "worked well" and "worked") [ Time Frame: 8 days ]
Change History Complete list of historical versions of study NCT00976716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • Pain intensity (VAS:Visual Analog Scale) of pain at rest (spontaneous pain) and active movement pain [ Time Frame: 8 days ]
  • Pain intensity differences in pain at rest (spontaneous pain) and active movement pain [ Time Frame: 8 days ]
  • 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 ]
  • 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 ]
  • Severity of inflammatory symptoms (each of swelling, redness, and local burn) [ Time Frame: 8 days ]
  • Patient Impressions (the proportion of subjects who have rated "worked well" and "worked") [ Time Frame: 4 days ]
  • The assessment of safety [ Time Frame: 8 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Official Title  ICMJE An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain
Brief Summary To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Celecoxib
Intervention: Drug: Celecoxib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2009)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976716
Other Study ID Numbers  ICMJE A3191357
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

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