Phase 4 N=278 Randomized Treatment

Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

Ankle Sprain

Bottom Line

View on ClinicalTrials.gov: NCT00446797 ↗

Enrolled (actual)

278

Serious AEs

—

Results posted

Jun 2009

Primary outcome: Primary: Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population — -44.88; -40.76 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Non-selective NSAIDS (Drug); Celecoxib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population	-44.88; -40.76	—
SECONDARY Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population	-29.25; -25.98; -44.87; -40.75; -61.17; -57.89	—
SECONDARY Number of Subjects Responding (Improving) - MITT Population	91; 79; 43; 54; 124; 116	0.1591
SECONDARY Subject's Global Assessment of Ankle Injury	1; 1; 40; 31; 76; 80	0.2411
SECONDARY Physician Global Assessment of Ankle Injury	20; 12; 71; 79; 40; 38	0.7223
SECONDARY Pain Relief - MITT Population	8; 5; 25; 33; 49; 52	0.2900
SECONDARY Subject Assessment of Normal Function / Activity	5; 2; 40; 30; 59; 55	0.0846
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1	5.71; 5.90; 3.81; 4.44; 2.08; 2.38	0.395
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2	3.25; 3.36; 2.07; 2.40; 0.83; 1.16	0.604
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3	4.34; 4.41; 2.90; 3.26; 1.41; 1.74	0.705
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4	3.64; 4.23; 2.58; 2.92; 1.14; 1.43	0.017 sig
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index	4.24; 4.48; 2.84; 3.26; 1.37; 1.68	0.229
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A	5.40; 5.37; 3.65; 4.07; 1.78; 1.90	0.954
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B	3.72; 3.64; 2.43; 2.38; 1.17; 1.26	0.924
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C	5.10; 5.11; 3.58; 3.69; 1.65; 1.62	0.929
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D	5.29; 5.39; 4.04; 4.04; 1.84; 1.87	0.779
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E	2.70; 2.67; 1.81; 1.69; 0.80; 0.78	0.944
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F	2.97; 2.87; 1.90; 1.86; 0.68; 0.82	0.842
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G	3.33; 2.99; 2.13; 2.06; 1.07; 1.10	0.404
SECONDARY Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index	4.07; 4.01; 2.79; 2.83; 1.28; 1.33	0.887

Summary

To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.

Eligibility Criteria

Inclusion Criteria

Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.

Exclusion Criteria

Patients who have a similar injury of the same joint within the last six months; or
clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
evidence of fractures; or non-removable full cast of any tipe; or
presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00446797). 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.