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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Funabashi, Chiba, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00976716
Pfizer
Completed
An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain

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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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00976716
A3191357
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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