Trial · NCT02528253
Outcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 66
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Baseline, Week 16 | ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Baseline, Week 16 | ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | Baseline, Week 16 | ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline, Week 64 | ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). 'Number analyzed' (n)= participants evaluable for this outcome measure (OM) at specified time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline, Weeks 64 and 80 | ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'number analyzed' = participants evaluable for this outcome measure at specified time points. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Baseline, Week 64 | ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'Number analyzed' = participants evaluable for this outcome measure at specified time point. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) | Baseline, Weeks 16, 24 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. Overall Number of Participants analyzed(N)=participants evaluable for this outcome measure (OM). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N=participants evaluable for this OM. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N =participants evaluable for this OM. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56 | Baseline, Weeks 16, 24 and 56 | ITT population.Data were not collected after W16 in placebo arm for this OM,as those who met criteria to continue,switched to active treatment with tanezumab(tan) after W16.N=participants evaluable for this OM.Intent of study was to compare tan V placebo for data up to \& including W16 \& comparisons of tan Vs tramadol for data up to \& including W56. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data | Baseline, Week 64 | ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time points. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data | Baseline, Week 64 | ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'number analyzed' = participants evaluable for this OM at specified time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data | Baseline, Week 64 | ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n' = participants evaluable for this OM at specified time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 | ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to \& including W16 \& comparisons of tanezumab Vs tramadol for data up to \& including W56. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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