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Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Diclofenac
Celecoxib
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

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

Inclusion criteria:

  • Aged between 18 and 65 years
  • Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)
  • Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode

Exclusion criteria:

  • Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain
  • Low back pain from major trauma or visceral disorder
  • Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment

Secondary Outcome Measures

Subject's quality of life, as measured by the SF-36 Health Survey
Physical examination
Pain relief score
Vital signs
Adverse events
Change from baseline in VAS pain intensity assessment
Categorical pain intensity score
Subject's global assessment score
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability

Full Information

First Posted
March 17, 2008
Last Updated
January 29, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00640432
Brief Title
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
Official Title
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
75 mg oral capsule twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
Primary Outcome Measure Information:
Title
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Subject's quality of life, as measured by the SF-36 Health Survey
Time Frame
Day 7
Title
Physical examination
Time Frame
Days 3 and 7
Title
Pain relief score
Time Frame
Days 3 and 7
Title
Vital signs
Time Frame
Days 3 and 7
Title
Adverse events
Time Frame
Days 3 and 7
Title
Change from baseline in VAS pain intensity assessment
Time Frame
Day 7
Title
Categorical pain intensity score
Time Frame
Days 3 and 7
Title
Subject's global assessment score
Time Frame
Days 3 and 7
Title
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability
Time Frame
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: Aged between 18 and 65 years Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS) Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode Exclusion criteria: Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain Low back pain from major trauma or visceral disorder Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug
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
Salvador
State/Province
BA
ZIP/Postal Code
40420-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74043-110
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74075-020
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74605-050
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Londrina
State/Province
PR
ZIP/Postal Code
86010-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21215-020
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191064&StudyName=Safety%20And%20Efficacy%20Of%20Celecoxib%20Versus%20Sodium%20Diclofenac%20In%20The%20Treatment%20Of%20Acute%20Low%20Back%20Pain
Description
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Learn more about this trial

Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

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