Phase 3
N=80
An Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00976716 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2011
Primary outcome: Primary: Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") — 70 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Celecoxib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Impressions at Final Visit (the Number of Participants Who Have Rated "Excellent" and "Good") |
70 | — |
| SECONDARY Patient Impressions Within 8 Days Post-first Dose (the Number of Subjects Who Have Rated "Excellent" and "Good") |
44; 48; 55; 60; 60 | — |
| SECONDARY Pain Intensity (PI) of Pain at Rest (Spontaneous Pain) as Measured by Visual Analog Scale (VAS) Within 8 Days Post-first Dose |
59.9; 47.3; 42.5; 40.3; 38.1; 34.8 | — |
| SECONDARY PI of Pain on Active Movement as Measured by VAS Within 8 Days Post-first Dose |
75.5; 61.4; 55.3; 51.5; 49.3; 45.5 | — |
| SECONDARY Pain Intensity Differences (PID) in Pain at Rest (Spontaneous Pain) Within 8 Days Post-first Dose |
12.6; 17.4; 19.6; 21.8; 25.1; 30.9 | — |
| SECONDARY PID in Pain on Active Movement Within 8 Days Post-first Dose |
14.3; 20.4; 24.3; 26.5; 30.3; 36.1 | — |
| SECONDARY Sum of Pain Intensity Differences (SPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose |
99.3; 118.2 | — |
| SECONDARY Peak Pain Intensity Difference (PPID) for Pain at Rest (Spontaneous Pain) and on Active Movement Until 6 Hours Post-first Dose |
22.2; 26.7 | — |
| SECONDARY Severity of Inflammatory Symptoms (Swelling) Within 8 Days Post-first Dose |
0; 5; 38; 41; 24; 69 | — |
| SECONDARY Severity of Inflammatory Symptoms (Redness) Within 8 Days Post-first Dose |
16; 51; 64; 73; 40; 28 | — |
| SECONDARY Severity of Inflammatory Symptoms (Localized Warmth) Within 8 Days Post First Dose |
8; 63; 66; 76; 43; 17 | — |
| SECONDARY Withdrawal Due to Lack of Efficacy |
— | — |
| SECONDARY Summary of Adverse Events |
10; 8; 0; 0; 0; 0 | — |
Summary
To investigate efficacy, safety and tolerability of Celecoxib in patients with posttraumatic pain for the duration of 8 days.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00976716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.