Ankle SprainPhase 4NCT00446797
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
A Phase 4 study testing Non-selective NSAIDS and Celecoxib in people with Ankle Sprain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 16 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Non-selective NSAIDS and Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 16 sitesin 8 countries
- Study dates
- May 2007to Apr 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
Brazil4 sites
Pfizer Investigational Site
Goiânia, Goiás, 74075-020
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 20221-161
Pfizer Investigational Site
São Paulo, São Paulo, 01221-900
Pfizer Investigational Site
São Paulo, São Paulo, 02720-000
Mexico4 sites
Pfizer Investigational Site
Mexico City, Mexico City, 10700
Pfizer Investigational Site
México DF, 03020
Pfizer Investigational Site
San Nicolás de los Garza, Nuevo León, 66451
Pfizer Investigational Site
Toluca, State of Mexico, 50180
Jordan3 sites
Pfizer Investigational Site
Amman, 11181 Jordan
Pfizer Investigational Site
Amman, 11193 Jordan
Pfizer Investigational Site
Amman, 22110 Jordan
Costa Rica1 site
Pfizer Investigational Site
San Antonio Guadalupe, Guadalupe, San Jose
About this study
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
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.
- Conditions
- Ankle Sprain
- Being tested
- Non-selective NSAIDS, Celecoxib
- Keywords
- Ankle sprain, acute pain, NSAID, celecoxib,
- Medical subject headings
- Ankle Injuries, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-selective NSAIDSDrug
Non-selective NSAIDs administered at usual (standard) doses.
CelecoxibDrug
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Non-Selective NSAIDS | Active comparator | nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain. Receives: Drug: Non-selective NSAIDS |
| Celecoxib | Experimental | Not described Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and day 3
Secondary outcomes (19)
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
Measured: Baseline and days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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).
Measured: Days 2, 3 and 7
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)
Measured: Days 3 and 7
Pain Relief - MITT Population
Subject's response to the statement "My relief from starting pain is". Scale from 0 = None to 4 = Complete.
Measured: Days 2, 3 and 7
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)
Measured: Days 2, 3 and 7
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
Measured: Days 1, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
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
Measured: Days 2, 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446797
- Sponsor's protocol ID
- A3191332
- Status last verified
- Feb 2021
- First submitted
- 9 Mar 2007
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
PubMed 32797734
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00446797
- Acronym / sponsor ID
- A3191332
- Conditions
- Ankle Sprain
- Keywords
- Ankle sprain, acute pain, NSAID, celecoxib,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Posted 10 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Selective NSAIDS | Active comparator | Drug: Non-selective NSAIDSnsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain. |
| Celecoxib | Experimental | Drug: Celecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-selective NSAIDSNon-selective NSAIDs administered at usual (standard) doses. | Drug | Non-Selective NSAIDS |
| Celecoxibcelecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days. | Drug | Celecoxib |
Primary outcome
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population
Time frame: Baseline and day 3
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
19 secondary outcomes
Change From Baseline in Pain Visual Analog Scale (VAS) - Modified Intent to Treat Population
Time frame: Baseline and days 2, 3 and 7
Number of Subjects Responding (Improving) - MITT Population
Time frame: Days 2, 3 and 7
Subject's Global Assessment of Ankle Injury
Time frame: Days 2, 3 and 7
Physician Global Assessment of Ankle Injury
Time frame: Days 3 and 7
Pain Relief - MITT Population
Time frame: Days 2, 3 and 7
Subject Assessment of Normal Function / Activity
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 1
Time frame: Days 1, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 2
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 3
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Question 4
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Severity Index
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5A
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5B
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5C
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5D
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5E
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5F
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Question 5G
Time frame: Days 2, 3 and 7
Modified Brief Pain Inventory Short Form (m-BPI-sf) - Pain Interference Index
Time frame: Days 2, 3 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32797734Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Ankle Sprain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Comparison of the Effects of Hip and Ankle Focused Progressive Exercise Training on Lower Extremity Function in Athletes With Chronic Ankle Instability
Ankle Sprains
RecruitingObservational study
Computed Tomography With Stress Maneuvers for Evaluation of Distal Tibiofibular Syndesmosis Instability (CTMETS)
Ankle Sprain
Not yet recruiting
Study of the AxisBoard Single-Leg Balance Board in Adults With Lateral Ankle Sprain
Ankle Sprains, Lateral Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-selective NSAIDS and Celecoxib in people with Ankle Sprain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 16 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Brazil, Mexico, Jordan, Costa Rica, Ecuador and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at Day 3 in Pain Visual Analog Scale (VAS) - Per Protocol Population (time frame: Baseline and day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.