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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

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Avellaneda, Buenos Aires, 1872 Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain, Sprains and Strains, Sprain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00671320
Pfizer
Completed
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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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