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

NCT00976716 | Completed Phase 3 Results

• 1 other identifier: A3191357
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Pain

Keywords

posttraumatic pain

Outcome Measures

Primary Outcomes (1)

• Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good")

  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.

  8 days

Secondary Outcomes (12)

• Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good")

  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)

• Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose

  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)

• PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose

  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)

• Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose

  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)

• PID in Pain on Active Movement Within 8 Days Post-first Dose

  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)

Study Arms (1)

Celecoxib

EXPERIMENTAL

Drug: Celecoxib

Interventions

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

Celecoxib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (11)

Pfizer Investigational Site

Funabashi, Chiba, Japan

Location

Pfizer Investigational Site

Ichikawa, Chiba, Japan

Location

Pfizer Investigational Site

Matsudo, Chiba, Japan

Location

Pfizer Investigational Site

Sagamihara, Kanagawa, Japan

Location

Pfizer Investigational Site

Ageo, Saitama, Japan

Location

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Location

Pfizer Investigational Site

Edogawaku, Tokyo, Japan

Location

Pfizer Investigational Site

Kotoku, Tokyo, Japan

Location

Pfizer Investigational Site

Nerimaku, Tokyo, Japan

Location

Pfizer Investigational Site

Toshimaku, Tokyo, Japan

Location

Pfizer Investigational Site

Kofu, Yamanashi, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 2, 2021
• Results First Posted: May 19, 2011

Record last verified: 2021-01

Locations

JP (11)