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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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
valdecoxib
diclofenac
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring acute low back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline

Secondary Outcome Measures

Patient global evaluation
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
Pain Relief
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
VAS Pain Intensity (0-100 mm)
Categorical Pain Intensity

Full Information

First Posted
March 28, 2008
Last Updated
April 7, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00649610
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
acute low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac 75 mg twice daily (BID) for 7 days
Primary Outcome Measure Information:
Title
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Patient global evaluation
Time Frame
Day 3 and Day 7
Title
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
Time Frame
Day 7
Title
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
Time Frame
Day 7
Title
Pain Relief
Time Frame
Day 3 and Day 7
Title
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
Time Frame
Day 7
Title
VAS Pain Intensity (0-100 mm)
Time Frame
Day 7
Title
Categorical Pain Intensity
Time Frame
Day 3 and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bs. As.
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1221ACI
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Goiania
State/Province
Goias
ZIP/Postal Code
74085-450
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80430-210
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Petropolis
State/Province
Rio de Janeiro
ZIP/Postal Code
25620-040
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04029-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-012
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
ZIP/Postal Code
05001-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
D.c.
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota D.c
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali-valle
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cartago City
State/Province
Cartago
ZIP/Postal Code
7051
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Hatillo
State/Province
San Jose
ZIP/Postal Code
476-1002
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Toluca
State/Province
Edo. de Mexico
ZIP/Postal Code
50080
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Puebla
ZIP/Postal Code
72000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Puebla
ZIP/Postal Code
72070
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Puebla
ZIP/Postal Code
72410
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
LIMA 27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
DF
ZIP/Postal Code
1020
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
DF
ZIP/Postal Code
1051
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
DF
ZIP/Postal Code
1070
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471012&StudyName=Randomized%2C%20Double%20Blind%2C%20Multicenter%20Study%20of%20the%20Safety%20and%20Efficacy%20of%20Valdecoxib%2040%20mg%20Once%20Daily%20Compared%20With%20Diclofenac%2075%20
Description
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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

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