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

Purpose

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

Condition	Intervention	Phase
Pain	Drug: Celecoxib	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Multicenter Study To Evaluate The Efficacy, Safety And Tolerability Of Celecoxib (YM177) In Patients With Posttraumatic Pain

Resource links provided by NLM:

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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.

Secondary Outcome 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) ] [ 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.

Enrollment:	80
Study Start Date:	September 2009
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Celecoxib	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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976716

Locations

Japan
Pfizer Investigational Site
Funabashi, Chiba, Japan
Pfizer Investigational Site
Ichikawa, Chiba, Japan
Pfizer Investigational Site
Matsudo, Chiba, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Ageo, Saitama, Japan
Pfizer Investigational Site
Saitama-shi, Saitama, Japan
Pfizer Investigational Site
Edogawaku, Tokyo, Japan
Pfizer Investigational Site
Kotoku, Tokyo, Japan
Pfizer Investigational Site
Nerimaku, Tokyo, Japan
Pfizer Investigational Site
Toshimaku, Tokyo, Japan
Pfizer Investigational Site
Kofu, Yamanashi, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00976716 History of Changes
Other Study ID Numbers:	A3191357
Study First Received:	September 11, 2009
Results First Received:	October 25, 2010
Last Updated:	April 25, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

posttraumatic pain

Additional relevant MeSH terms:

Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013