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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| celecoxib | Experimental |
| |
| tramadol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug | 200 mg capsules BID for 6 weeks |
| |
| tramadol HCL |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35126 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib | 200 mg capsules two times a day (BID) for 6 weeks |
| FG001 | Tramadol HCL | 50 mg capsules four times a day (QID) for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
50 mg capsules QID for 6 weeks |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35242 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Anaheim | California | 92801 | United States |
| Pfizer Investigational Site | Long Beach | California | 90806 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | Sacramento | California | 95823 | United States |
| Pfizer Investigational Site | Sacramento | California | 95825 | United States |
| Pfizer Investigational Site | Wildomar | California | 92595 | United States |
| Pfizer Investigational Site | Boulder | Colorado | 80304 | United States |
| Pfizer Investigational Site | Colorado Springs | Colorado | 80904 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80220 | United States |
| Pfizer Investigational Site | Cos Cob | Connecticut | 06807 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32257 | United States |
| Pfizer Investigational Site | Pinellas Park | Florida | 33781 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pfizer Investigational Site | Woodstock | Georgia | 30189 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67206 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67214 | United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21218 | United States |
| Pfizer Investigational Site | Columbia | Maryland | 21045 | United States |
| Pfizer Investigational Site | Rockville | Maryland | 20852 | United States |
| Pfizer Investigational Site | Wheaton | Maryland | 20902 | United States |
| Pfizer Investigational Site | Saint Paul | Minnesota | 55108 | United States |
| Pfizer Investigational Site | Jackson | Mississippi | 39202 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65807 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68134 | United States |
| Pfizer Investigational Site | New Windsor | New York | 12553 | United States |
| Pfizer Investigational Site | New York | New York | 10022-1009 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | Williamsville | New York | 14221 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97219 | United States |
| Pfizer Investigational Site | Bridgeville | Pennsylvania | 15017 | United States |
| Pfizer Investigational Site | Camp Hill | Pennsylvania | 17011 | United States |
| Pfizer Investigational Site | Columbia | South Carolina | 29204 | United States |
| Pfizer Investigational Site | North Charleston | South Carolina | 29406 | United States |
| Pfizer Investigational Site | Bristol | Tennessee | 37620 | United States |
| Pfizer Investigational Site | Collierville | Tennessee | 38017 | United States |
| Pfizer Investigational Site | Johnson City | Tennessee | 37601 | United States |
| Pfizer Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Pfizer Investigational Site | New Tazewell | Tennessee | 37825 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77701 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77706 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75230 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75240 | United States |
| Pfizer Investigational Site | Grapevine | Texas | 76051 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | San Angelo | Texas | 76904 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78217 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23294 | United States |
| Pfizer Investigational Site | Weber City | Virginia | 24290 | United States |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib | 200 mg capsules two times a day (BID) for 6 weeks |
| BG001 | Tramadol HCL | 50 mg capsules four times a day (QID) for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF). | Posted | Number | participants | Week 6 or Early Termination (ET) |
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| 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. | ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385. | Posted | Mean | Standard Error | scores on a scale | Baseline, Week 6/ET |
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| 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. | ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385. | Posted | Mean | Standard Error | mm | Baseline, Week 6/ET |
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| 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. | ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367. | Posted | Number | participants | Week 6/ET |
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| 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. | ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361. | Posted | Number | participants | Week 6/ET |
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| 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. | ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389. | Posted | Mean | Standard Error | scores on a scale | Baseline, Week 6/ET |
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| 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. | ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367. | Posted | Mean | Standard Error | scores on a scale | Baseline, Week 6/ET |
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| 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. | ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl. | Posted | Mean | Standard Error | scores on a scale | Baseline, Week 6/ET |
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| 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. | ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365. | Posted | Number | participants | Baseline, Week 6/ET |
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| 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. | ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl. | Posted | Mean | Standard Error | scores on a scale | Baseline, Week 6/ET |
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| 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. | ITT. | Posted | Number | participants | Weeks 1, 3, and 6/ET |
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| 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). | ITT. Number of subjects with Patient's Satisfaction Questionnaire (with pain relief scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364. | Posted | Number | participants | Week 6/ET |
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| 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). | ITT. Number of subjects with Patient's Satisfaction Questionnaire (with walking and bending ability scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364. | Posted | Number | participants | Week 6/ET |
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| 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). | ITT | Posted | Number | participants | Week 6/ET |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | 200 mg capsules two times a day (BID) for 6 weeks | 1 | 89 | ||||
| EG001 | Tramadol HCL | 50 mg capsules four times a day (QID) for 6 weeks | 0 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery bypass | Surgical and medical procedures | MedDRA (v11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (v11.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| > = 65 years |
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| Male |
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If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center. |
| Cochran-Mantel-Haenszel |
| 0.008 |
| 95 |
| Superiority or Other (legacy) |
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