PainPhase 4NCT00671320
A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle
A Phase 4 study testing valdecoxib and diclofenac in people with Pain and Sprains and Strains, run by Pfizer at 15 sites in 5 countries.
Trial summary
To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Sprains and Strains, Sprain
- What is being tested?
- valdecoxib and diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Dec 2002to Oct 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 had sprained their ankle within 48 hours
- The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
- At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
- Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms
Who cannot join
- Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
- Patients with a similar injury of the same joint within the last 6 months
- Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
- Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Colombia7 sites
Pfizer Investigational Site
Bogota, Cundinamarca, (57) 310-2322198
Pfizer Investigational Site
Bogota, Cundinamarca, (57) 310-8849622
Pfizer Investigational Site
Bogotá, Cundinarmarca, (571) 6 164278
Pfizer Investigational Site
Bucaramanga, Santander Department, (577) 6 395409
Pfizer Investigational Site
Cali, Valle del Cauca Department, (57) 315-5410469
Pfizer Investigational Site
Calli, Valle del Cauca Department, (57) 310-8259712
Pfizer Investigational Site
Medellín, Antioquia, (574) 5141516
Argentina3 sites
Pfizer Investigational Site
Avellaneda, Buenos Aires, 1872
Pfizer Investigational Site
Buenos Aires
Pfizer Investigational Site
San Isidro, Buenos Aires, 1642
Chile2 sites
Pfizer Investigational Site
Santiago, RM
Pfizer Investigational Site
Santiago
Peru2 sites
Pfizer Investigational Site
Lima, Lima Province, 27
Pfizer Investigational Site
Lima, Lima Province
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain
To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.
- Conditions
- Pain, Sprains and Strains, Sprain
- Being tested
- valdecoxib, diclofenac
- Keywords
- acute ankle sprain, acute pain, South America
- Medical subject headings
- Pain, Sprains and Strains, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valdecoxibDrug
valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
diclofenacDrug
diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
| Arm 2 | Active comparator | Not described Receives: Drug: diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's assessment of ankle pain VAS
Measured: Day 4
Secondary outcomes (6)
Time to onset of pain relief
Measured: 0, 15, 30, 45, and 60 minutes after first dose
Physician's global assessment of ankle injury
Measured: Days 1, 4, and 7
Patient's global assessment of ankle injury
Measured: Days 1, 4 and 7
Patient's assessment of normal function/activity
Measured: Days 1 to 7
Patient's and physician's satisfaction assessments
Measured: Day 7
Patient's assessment of ankle pain on visual analogue scale (VAS)
Measured: Days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startDec 2002
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671320
- Sponsor's protocol ID
- VALA-0513-146
- Other IDs
- A3471037
- Status last verified
- Apr 2008
- First submitted
- 31 Mar 2008
- Last updated
- 5 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain
- ClinicalTrials.gov ID
- NCT00671320
- Acronym / sponsor ID
- VALA-0513-146
- Conditions
- Pain, Sprains and Strains, Sprain
- Keywords
- acute ankle sprain, acute pain, South America
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Oct 2003 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: valdecoxib |
| Arm 2 | Active comparator | Drug: diclofenac |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients had sprained their ankle within 48 hours
- The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
- At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
- Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms
Key exclusion criteria (4 listed)
- Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
- Patients with a similar injury of the same joint within the last 6 months
- Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
- Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.
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 |
|---|---|---|
| valdecoxibvaldecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7 | Drug | Arm 1 |
| diclofenacdiclofenac 75 mg capsule by mouth twice daily (BID) for 7 days | Drug | Arm 2 |
Primary outcome
Patient's assessment of ankle pain VAS
Time frame: Day 4
6 secondary outcomes
Time to onset of pain relief
Time frame: 0, 15, 30, 45, and 60 minutes after first dose
Physician's global assessment of ankle injury
Time frame: Days 1, 4, and 7
Patient's global assessment of ankle injury
Time frame: Days 1, 4 and 7
Patient's assessment of normal function/activity
Time frame: Days 1 to 7
Patient's and physician's satisfaction assessments
Time frame: Day 7
Patient's assessment of ankle pain on visual analogue scale (VAS)
Time frame: Days 1 to 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valdecoxib and diclofenac in people with Pain and Sprains and Strains, run by Pfizer at 15 sites in 5 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 4 inclusion and 4 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 5 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Colombia, Argentina, Chile, Peru, Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient's assessment of ankle pain VAS (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2008.