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

NCT00976716

Last updated date
Study Location
Pfizer Investigational Site
Funabashi, Chiba, , Japan
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

PainAn Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
NCT00976716
  1. Funabashi, Chiba
  2. Ichikawa, Chiba
  3. Matsudo, Chiba
  4. Sagamihara, Kanagawa
  5. Ageo, Saitama
  6. Saitama-shi, Saitama
  7. Edogawaku, Tokyo
  8. Kotoku, Tokyo
  9. Nerimaku, Tokyo
  10. Toshimaku, Tokyo
  11. Kofu, Yamanashi
ALL GENDERS
20 Years+
years
MULTIPLE SITES
PainA Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
NCT00651300
  1. Port Macquarie, New South Wales
  2. Randwick, New South Wales
  3. Westmead, New South Wales
  4. Coopers Plain, Queensland
  5. Townsville, Queensland
  6. Heidelberg, Victoria
  7. Prahran, Victoria
  8. Perth, Western Australia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PainPlacebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
NCT00159640
  1. Warrawong, New South Wales
  2. Westmead, New South Wales
  3. Kippa Ring, Queensland
  4. Maroochydore, Queensland
  5. Bedford Park, South Australia
  6. Perth, Western Australia
  7. Woodville,
  8. Kelowna, British Columbia
  9. Halifax, Nova Scotia
  10. Toronto, Ontario
  11. Sherbrooke, Quebec
  12. Ste-foy, Quebec
  13. Brno,
  14. Ceske Budejovice,
  15. CZ-Praha 8,
  16. Plzen,
  17. Praha 5,
  18. Arnhem,
  19. Breda,
  20. Kampen,
  21. Roosendaal,
  22. Rotterdam,
  23. Stadskanaal,
  24. Barcelona,
  25. Granada,
  26. Madrid,
  27. Malaga,
  28. Sevilla,
  29. Portsmouth, Hants
  30. Northampton, Northants
  31. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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

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 CenterPfizer
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