Trial · NCT02528253
A Phase 3 Study of Tanezumab for Chronic Low Back Pain
NCT02528253, Phase 3, Completed, Pfizer; results first posted 2020-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Study of Tanezumab for Chronic Low Back Pain. Trials, record NCT02528253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02528253
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study of Tanezumab for Chronic Low Back Pain
- NCT number
- NCT02528253
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,832 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Low Back Pain
- Interventions
- Placebo to Week 16; tanezumab 5mg SC, Placebo to Week 16, tanezumab 10 mg SC, Tanezumab 5 mg SC, Tanezumab 10 mg SC, Tramadol PR oral
- First posted
- 2015-08-19
- Last updated
- 2020-02-21
- Other registries' IDs
- eudract:2012-005495-34
- Results first posted
- 2020-02-21
Source ClinicalTrials.gov
Registered outcomes66
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Baseline, Week 16 | Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Secondary | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Baseline, Week 16 | The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ from the total number of items checked ranged from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. |
| Secondary | Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | Baseline, Week 16 | Average LBP was assessed on an 11-point NRS captured through an IRT. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| 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 | Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once daily from baseline up to week 16, and once weekly from week 16 to week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. 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. |
| Secondary | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64 | Baseline, Week 64 | Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| 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 | The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. 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. |
| Secondary | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data | Baseline, Weeks 64 and 80 | The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. |
| 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 | PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. 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. |
| Secondary | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data | Baseline, Week 64 | PGA of LBP was assessed by asking a question to participants: "Considering all the ways your low back pain affects you, how are you doing today?" Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| 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 | Average LBP was assessed on an 11-point NRS captured through an IRT. LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0%; \>= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to \[=\] 100 %) in LBPI from baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Missing data was imputed using mixed BOCF/LOCF.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.Also, 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. |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 registered outcomesOutcomes66
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 outcomesResults by group2,429
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Placebo | -2.68 | Standard Error 0.15 | units on a scale | |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Pooled Tanezumab 5 mg | -2.98 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Pooled Tanezumab 10 mg | -3.08 | Standard Error 0.14 | units on a scale | |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16 | Tramadol | -2.81 | Standard Error 0.12 | units on a scale | |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Placebo | -4.95 | Standard Error 0.36 | units on a scale | |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Pooled Tanezumab 5 mg | -6.27 | Standard Error 0.35 | units on a scale | |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Pooled Tanezumab 10 mg | -6.69 | Standard Error 0.35 | units on a scale | |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo | Tramadol | -5.21 | Standard Error 0.30 | units on a scale | |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | Placebo | -2.68 | Standard Error 0.15 | units on a scale | |
| Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16 | Pooled Tanezumab 5 mg | -2.98 | Standard Error 0.14 | units on a scale |
1 to 10 of 2,429Source ClinicalTrials.gov
See all 2,429 results by groupParticipant flow25
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Followed by Tanezumab 5 mg | 205 | |
| Overall Study | STARTED | Placebo Followed by Tanezumab 10 mg | 204 | |
| Overall Study | STARTED | Pooled Tanezumab 5 mg | 407 | |
| Overall Study | STARTED | Pooled Tanezumab 10 mg | 407 | |
| Overall Study | STARTED | Tramadol | 602 | |
| Overall Study | Intent to Treat Population | Placebo Followed by Tanezumab 5 mg | 202 | |
| Overall Study | Intent to Treat Population | Placebo Followed by Tanezumab 10 mg | 204 | |
| Overall Study | Intent to Treat Population | Pooled Tanezumab 5 mg | 407 | |
| Overall Study | Intent to Treat Population | Pooled Tanezumab 10 mg | 407 | |
| Overall Study | Intent to Treat Population | Tramadol | 605 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events392
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo (Week 16) | 3 | 215 | |
| other | Constipation | Gastrointestinal disorders | Safety Evaluation: Tanezumab 5 mg | 9 | 506 | |
| other | Constipation | Gastrointestinal disorders | Safety Evaluation: Tanezumab 10 mg | 12 | 502 | |
| other | Constipation | Gastrointestinal disorders | Tramadol | 52 | 602 | |
| other | Nausea | Gastrointestinal disorders | Placebo (Week 16) | 5 | 215 | |
| other | Nausea | Gastrointestinal disorders | Safety Evaluation: Tanezumab 5 mg | 16 | 506 | |
| other | Nausea | Gastrointestinal disorders | Safety Evaluation: Tanezumab 10 mg | 16 | 502 | |
| other | Nausea | Gastrointestinal disorders | Tramadol | 78 | 602 | |
| other | Nasopharyngitis | Infections and infestations | Placebo (Week 16) | 11 | 215 | |
| other | Nasopharyngitis | Infections and infestations | Safety Evaluation: Tanezumab 5 mg | 31 | 506 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Week 16) | 1 | 215 |
| Total, all-cause mortality | Safety Evaluation: Tanezumab 5 mg | 2 | 506 |
| Total, all-cause mortality | Safety Evaluation: Tanezumab 10 mg | 2 | 502 |
| Total, all-cause mortality | Tramadol | 1 | 602 |
| Total, other adverse events | Placebo (Week 16) | 65 | 215 |
| Total, other adverse events | Safety Evaluation: Tanezumab 5 mg | 201 | 506 |
| Total, other adverse events | Safety Evaluation: Tanezumab 10 mg | 203 | 502 |
| Total, other adverse events | Tramadol | 275 | 602 |
| Total, serious adverse events | Placebo (Week 16) | 7 | 215 |
| Total, serious adverse events | Safety Evaluation: Tanezumab 5 mg | 21 | 506 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02528253
GET https://conductscience.org/api/trials/v1/NCT02528253/registered?page=2