An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
NCT00976716
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- 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"
- 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
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Descriptive Information | ||||
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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
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 | 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:
"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more
"Inflammation" Categorical: "Mild", "Moderate" or "Severe" Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |