A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Six Week Double-Blind, Randomized, Multicenter Comparison Study Of The Analgesic Effectiveness Of Celecoxib 200 Mg BID Compared To Tramadol Hydrochloride 50 Mg QID In Subjects With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662558
• Other study ID #: A3191338
• Status: Completed
• Phase: Phase 3
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used

Exclusion Criteria:

• The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• celecoxib
200 mg capsules BID for 6 weeks
• tramadol HCL
50 mg capsules QID for 6 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boulder	Colorado
United States	Pfizer Investigational Site	Bridgeville	Pennsylvania
United States	Pfizer Investigational Site	Bristol	Tennessee
United States	Pfizer Investigational Site	Camp Hill	Pennsylvania
United States	Pfizer Investigational Site	Collierville	Tennessee
United States	Pfizer Investigational Site	Colorado Springs	Colorado
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Columbia	Maryland
United States	Pfizer Investigational Site	Cos Cob	Connecticut
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Grapevine	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jackson	Mississippi
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Johnson City	Tennessee
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	New Tazewell	Tennessee
United States	Pfizer Investigational Site	New Windsor	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	North Charleston	South Carolina
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Pinellas Park	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Sacramento	California
United States	Pfizer Investigational Site	Saint Louis	Missouri
United States	Pfizer Investigational Site	Saint Paul	Minnesota
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Angelo	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Weber City	Virginia
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Wheaton	Maryland
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wildomar	California
United States	Pfizer Investigational Site	Williamsville	New York
United States	Pfizer Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)	A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).	Week 6 or Early Termination (ET)
Secondary	Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain	NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.	Baseline, Week 6/ET
Secondary	Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)	VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, "During the past day, how much back pain did you have?", the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.	Baseline, Week 6/ET
Secondary	Patient's Global Assessment of Disease Activity	Number of subjects with a graded level of disease activity using the Patient's Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.	Week 6/ET
Secondary	Physician's Global Assessment of Disease Activity	Number of subjects with a physician's grading of disease activity using the Physician's Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.	Week 6/ET
Secondary	Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score	Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.	Baseline, Week 6/ET
Secondary	Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)	m-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.	Baseline, Week 6/ET
Secondary	Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale	MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.	Baseline, Week 6/ET
Secondary	Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores	The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.	Baseline, Week 6/ET
Secondary	Change From Baseline in Work Limitations Questionnaire (WLQ)	The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.	Baseline, Week 6/ET
Secondary	Patient's Global Evaluation of Study Medication	Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.	Weeks 1, 3, and 6/ET
Secondary	Patient's Satisfaction Questionnaire (With Pain Relief Scale)	Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).	Week 6/ET
Secondary	Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)	Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).	Week 6/ET
Secondary	Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ	Subjects were successful responders if they had: > = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); > = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and < 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability).	Week 6/ET

External Links

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