Trial · NCT00924664
Long Term Safety Study of Tanezumab in Chronic Low Back Pain
NCT00924664, Phase 2, Terminated, Pfizer; results first posted 2021-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Safety Study of Tanezumab in Chronic Low Back Pain. Trials, record NCT00924664. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00924664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety Study of Tanezumab in Chronic Low Back Pain
- NCT number
- NCT00924664
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 849 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Low Back Pain
- Interventions
- Tanezumab 20 mg, Tanezumab 10 mg
- First posted
- 2009-06-19
- Last updated
- 2021-04-21
- Results first posted
- 2021-04-21
- Limitations and caveats
Due to FDA-imposed clinical hold, further study drug dosing stopped prematurely and study was terminated. Designation of outcomes as primary, secondary based on study team input as study did not specify them as primary or secondary.
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 112 days after last dose of study treatment (up to 448 days) | AE: any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | A4091012: Baseline, A4091039: Week 4 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | A4091012: Baseline, A4091039: Week 8 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 | A4091012: Baseline, A4091039: Week 16 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 | A4091012: Baseline, A4091039: Week 24 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 | A4091012: Baseline, A4091039: Week 32 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 | A4091012: Baseline, A4091039: Week 40 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 | A4091012: Baseline, A4091039: Week 48 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56 | A4091012: Baseline, A4091039: Week 56 | NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment. |
| Primary | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | A4091012: Baseline, A4091039: Week 4 | BPI-sf: 11-item self-report questionnaire consists of 5 questions, to assess severity and impact of pain on daily functions. Question/item 1-4 (Q1-Q4) measure impact of pain (worst, least, average, right now). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each item answered on 11-point scale ranging from 0 (no pain/interference) to 10 (pain as bad as you can imagine/completely interferes). |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 112 days after last dose of study treatment (up to 448 days) | Intent-to-treat (ITT) analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | A4091012: Baseline, A4091039: Week 4 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | A4091012: Baseline, A4091039: Week 8 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 16 | A4091012: Baseline, A4091039: Week 16 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 24 | A4091012: Baseline, A4091039: Week 24 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 32 | A4091012: Baseline, A4091039: Week 32 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 40 | A4091012: Baseline, A4091039: Week 40 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 48 | A4091012: Baseline, A4091039: Week 48 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 56 | A4091012: Baseline, A4091039: Week 56 | ITT analysis set. 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. Data was not collected for tanezumab 10 mg arm at Week 56 since none of the participants received dosing beyond Week 32 and safety assessment was only required for 16 weeks after treatment discontinuation due to clinical hold. | units on a scale | MEAN |
| PRIMARY | Change From A4091012 (NCT00876187) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Pain Scores (Worst, Least, Average, Right Now) at Week 4 | A4091012: Baseline, A4091039: Week 4 | ITT analysis set included all participants who received at least 1 dose of IV or SC study medication during this study, A4091039 (NCT00924664). 'Number Analyzed' signifies participants evaluated at specific time point for each arm group, respectively. | units on a scale | MEAN |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tanezumab 10 mg | AEs | 198 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tanezumab 20 mg | AEs | 370 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tanezumab 10 mg | SAEs | 15 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Tanezumab 20 mg | SAEs | 24 | Participants | |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Tanezumab 10 mg | Baseline | 0.89 | Standard Deviation 2.53 | units on a scale |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Tanezumab 20 mg | Baseline | 1.14 | Standard Deviation 2.81 | units on a scale |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Tanezumab 10 mg | Change at Week 4 | 0.34 | Standard Deviation 1.37 | units on a scale |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 4 | Tanezumab 20 mg | Change at Week 4 | 0.54 | Standard Deviation 2.12 | units on a scale |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | Tanezumab 10 mg | 0.42 | Standard Deviation 1.72 | units on a scale | |
| Change From A4091012 (NCT00876187) Baseline in Neuropathy Impairment Score (NIS) at Week 8 | Tanezumab 20 mg | 0.54 | Standard Deviation 1.84 | units on a scale |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tanezumab 10 mg | 322 | |
| Overall Study | STARTED | Tanezumab 20 mg | 527 | |
| Overall Study | Treated | Tanezumab 10 mg | 321 | |
| Overall Study | Treated | Tanezumab 20 mg | 527 | |
| Overall Study | COMPLETED | Tanezumab 10 mg | 0 | |
| Overall Study | COMPLETED | Tanezumab 20 mg | 0 | |
| Overall Study | NOT COMPLETED | Tanezumab 10 mg | 322 | |
| Overall Study | NOT COMPLETED | Tanezumab 20 mg | 527 |
Source ClinicalTrials.gov
Adverse events126
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 | Diarrhoea | Gastrointestinal disorders | Tanezumab 10 mg | 6 | 321 | |
| other | Diarrhoea | Gastrointestinal disorders | Tanezumab 20 mg | 18 | 527 | |
| other | Infusion site reaction | General disorders | Tanezumab 10 mg | 12 | 321 | |
| other | Infusion site reaction | General disorders | Tanezumab 20 mg | 17 | 527 | |
| other | Oedema peripheral | General disorders | Tanezumab 10 mg | 11 | 321 | |
| other | Oedema peripheral | General disorders | Tanezumab 20 mg | 32 | 527 | |
| other | Nasopharyngitis | Infections and infestations | Tanezumab 10 mg | 5 | 321 | |
| other | Nasopharyngitis | Infections and infestations | Tanezumab 20 mg | 13 | 527 | |
| other | Sinusitis | Infections and infestations | Tanezumab 10 mg | 12 | 321 | |
| other | Sinusitis | Infections and infestations | Tanezumab 20 mg | 14 | 527 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tanezumab 10 mg | ||
| Total, all-cause mortality | Tanezumab 20 mg | ||
| Total, other adverse events | Tanezumab 10 mg | 152 | 321 |
| Total, other adverse events | Tanezumab 20 mg | 277 | 527 |
| Total, serious adverse events | Tanezumab 10 mg | 15 | 321 |
| Total, serious adverse events | Tanezumab 20 mg | 24 | 527 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tanezumab 10 mg vs Tanezumab 20 mg: Number of Participants Using Concomitant Medication for Chronic Low Back Pain (CLBP) | Trial comparisons |
| Tanezumab 10 mg vs Tanezumab 20 mg: serious adverse events | Trial comparisons |
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/NCT00924664
GET https://conductscience.org/api/trials/v1/NCT00924664/registered?page=2