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

Ankle Sprain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446797
• Other study ID #: A3191332
• Status: Completed
• Phase: Phase 4
• Start date: May 2007
• Est. completion date: April 2008

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Ankle Injuries
• Ankle Sprain
• Sprains and Strains

Intervention

Drug:
• Non-selective NSAIDS
Non-selective NSAIDs administered at usual (standard) doses.
• Celecoxib
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Costa Rica	Pfizer Investigational Site	San Antonio Guadalupe	Guadalupe, San Jose
Ecuador	Pfizer Investigational Site	Quito	Pichincha
Egypt	Pfizer Investigational Site	Cairo
Jordan	Pfizer Investigational Site	Amman
Jordan	Pfizer Investigational Site	Amman
Jordan	Pfizer Investigational Site	Amman
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	México DF
Mexico	Pfizer Investigational Site	San Nicolas de los Garza	Nuevo León
Mexico	Pfizer Investigational Site	Toluca	Estado De México
Panama	Pfizer Investigational Site	Panama City
Peru	Pfizer Investigational Site	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Brazil,  Costa Rica,  Ecuador,  Egypt,  Jordan,  Mexico,  Panama,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population	Assessment of ankle pain by VAS: 100 mm horizontal line with left end being "No Pain" & right end being "Worst Possible Pain". Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at day 3 minus mean score at baseline	Baseline and day 3
Secondary	Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population	Assessment of ankle pain by VAS: 100 mm horizontal line, left end being "No Pain" & right end being "Worst Possible Pain". Participants drew vertical line on horizontal scale to best reflect current pain on full weight bearing of injured ankle. Distance from left end of line to mark. Change: mean score at observation minus mean score at baseline	Baseline and days 2, 3 and 7
Secondary	Number of Subjects Responding (Improving) - MITT Population	The number of subjects showing a response: a decrease of at least 20 mm (that is improvement) on the pain visual analog scale (VAS) scale	Days 2, 3 and 7
Secondary	Subject's Global Assessment of Ankle Injury	Subject response to question: "Considering all the ways your ankle injury affects you, how are you doing today?" Scale: 5 point from 1 = very good (no symptoms and no limitation of normal activities) to 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).	Days 2, 3 and 7
Secondary	Physician Global Assessment of Ankle Injury	Investigator evaluation of overall severity of ankle injury. Scale: 5 point from 1 = Very mild (very mild signs and symptoms of ankle sprain) to 5 =Very severe (very severe signs and symptoms of ankle sprain)	Days 3 and 7
Secondary	Pain Relief - MITT Population	Subject's response to the statement "My relief from starting pain is". Scale from 0 = None to 4 = Complete.	Days 2, 3 and 7
Secondary	Subject Assessment of Normal Function / Activity	Subject response to question: "How does your ankle injury affect your walking and normal activity?" Scale from 1 = Normal walking/activity and no pain to 5 = Severely restricted walking due to pain and can't resume normal activities (normal activities defined as all activity that a subject did on a routine basis, including work and recreation)	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q1: Subject response to 'describe your pain at its worst in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine	Days 1, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q2: Subject response to 'describe your pain at its least in the last 24 hours'. Scale: 0 = no pain to 10 = pain as bad as you can imagine	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q3: Subject response to 'describe your pain on the average'. Scale: 0 = no pain to 10 = pain as bad as you can imagine	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q4: Subject response to 'how much pain you have right now'. Scale: 0 = no pain to 10 = pain as bad as you can imagine	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Pain severity index is the average of the pain severity questions 1 to 4. Scale: 0 = no pain to 10 = pain as bad as you can imagine	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7
Secondary	Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index	m-BPI-sf questionnaire assessed pain severity and pain interference with functional activities during the 24 hour follow-up period.; The pain interference index is the average of pain interference questions 5A to 5G. Scale: 0 = does not interfere to 10 = completely interferes	Days 2, 3 and 7

External Links

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