Clinical trial NCT00976716: An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Official title: An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: posttraumatic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good")
timeFrame: 8 days
Secondary outcomes:
measure: Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")
timeFrame: 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)
measure: Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose
timeFrame: 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)
measure: PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose
timeFrame: 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)
measure: Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose
timeFrame: 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)
measure: PID in Pain on Active Movement Within 8 Days Post-first Dose
timeFrame: 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)
measure: Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
timeFrame: 6 hours
measure: Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose
timeFrame: Two, 4 and 6 hours post first dose
measure: Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose
timeFrame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
measure: Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose
timeFrame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
measure: Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose
timeFrame: Baseline, Days 4 (Visit 2) and 8 (Visit 3)
measure: Withdrawal Due to Lack of Efficacy
timeFrame: 8 days
measure: Summary of Adverse Events
timeFrame: 8 days
Other outcomes:
Locations:
city: Funabashi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Ichikawa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Matsudo
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Ageo
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Saitama-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Edogawaku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kotoku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Nerimaku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Toshimaku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Kofu
country: Japan
facility: Pfizer Investigational Site
state: Yamanashi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: