Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain

CompletadoFase 4ClinicalTrials.gov

ID: NCT00649610Tipo: INTERVENTIONALInicio: 1 de nov de 2002Fin estimado: 1 de may de 2003

Traducción no disponible, mostrando original

Resumen

The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
History of at least 1 reported episode of acute low back pain in the last 5 years

Criterios de exclusión

History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
Moderate to severe scoliosis
Back pain due to major trauma or visceral disorder
Unwilling to refrain from commencing concomitant physiotherapy
Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception

Intervenciones

drug

valdecoxib

valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day

drug

diclofenac

diclofenac 75 mg twice daily (BID) for 7 days

Ubicaciones

Pfizer Investigational Site

Bs. As., Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Randomized, Double Blind, Multicenter Study of the Safety... | EligiMed