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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bs. As., , Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

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

- 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

NCT00649610
Pfizer
Completed
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

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Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • 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
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: diclofenac
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
May 2003
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Colombia,   Costa Rica,   Ecuador,   Mexico,   Peru,   Venezuela
 
 
NCT00649610
A3471012
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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