Trial · NCT00876187
A Study of Tanezumab in Adults With Chronic Low Back Pain
NCT00876187, Phase 2, Completed, Pfizer; results first posted 2021-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tanezumab in Adults With Chronic Low Back Pain. Trials, record NCT00876187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00876187
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tanezumab in Adults With Chronic Low Back Pain
- NCT number
- NCT00876187
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,359 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Low Back Pain
- Interventions
Tanezumab 20 mg IV, Placebo for naproxen, Tanezumab 10 mg IV, Placebo for naproxen, Tanezumab 5 mg IV, Placebo for naproxen, Placebo for tanezumab, Naproxen, Placebo for tanezumab, Placebo for naproxen
- First posted
- 2009-04-06
- Last updated
- 2021-07-07
- Results first posted
- 2021-07-07
- Limitations and caveats
- Results for total duration of response as defined by days with a \>=30% and a \>=50% reduction from baseline in the daily average LBPI NRS score was not reported due changed in planned analysis.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity. |
| Secondary | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability. |
| Secondary | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | Participants answered: "Considering all ways your low back pain affects you, how are you doing today?" Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities). |
| Secondary | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. |
| Secondary | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported. |
| Secondary | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. |
| Secondary | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). 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 ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain. |
| Secondary | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Baseline, Week 2, 4, 8, 12, 16 | BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment. |
| Secondary | Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 16 | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. |
| Secondary | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2, 4, 8, 12, 16 | Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | units on scale | MEAN |
| SECONDARY | Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12, 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF | Baseline, Week 2, 4, 8, 12, 16 | ITT analysis set. BOCF method was used to impute missing values. Here, Overall number of participants analyzed = participants who were evaluable for this outcome measure and 'Number Analyzed' = participants who were evaluable for this outcome measure at given time points for each group, respectively. | units on a scale | MEAN |
| SECONDARY | Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. | days | MEDIAN |
| SECONDARY | Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF) | Week 2, 4, 8, 12, 16 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. BOCF method was used to impute missing values. | participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group643
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 Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Placebo | Baseline | 6.71 | Standard Deviation 1.37 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 5 mg | Baseline | 6.62 | Standard Deviation 1.36 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 10 mg | Baseline | 6.57 | Standard Deviation 1.39 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 20 mg | Baseline | 6.74 | Standard Deviation 1.48 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Naproxen 500 mg | Baseline | 6.77 | Standard Deviation 1.38 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Placebo | Change at Week 16 | -1.25 | Standard Deviation 2.01 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 5 mg | Change at Week 16 | -1.55 | Standard Deviation 2.07 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 10 mg | Change at Week 16 | -2.02 | Standard Deviation 2.40 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 20 mg | Change at Week 16 | -2.19 | Standard Deviation 2.52 | units on a scale |
| Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF) | Naproxen 500 mg | Change at Week 16 | -1.70 | Standard Deviation 2.28 | units on a scale |
1 to 10 of 643Source ClinicalTrials.gov
See all 643 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 | 233 | |
| Overall Study | STARTED | Tanezumab 5 mg | 233 | |
| Overall Study | STARTED | Tanezumab 10 mg | 298 | |
| Overall Study | STARTED | Tanezumab 20 mg | 297 | |
| Overall Study | STARTED | Naproxen 500 mg | 298 | |
| Overall Study | Treated | Placebo | 230 | |
| Overall Study | Treated | Tanezumab 5 mg | 232 | |
| Overall Study | Treated | Tanezumab 10 mg | 295 | |
| Overall Study | Treated | Tanezumab 20 mg | 295 | |
| Overall Study | Treated | Naproxen 500 mg | 295 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 participant flowAdverse events230
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 | Placebo | 6 | 230 | |
| other | Diarrhoea | Gastrointestinal disorders | Tanezumab 5 mg | 5 | 232 | |
| other | Diarrhoea | Gastrointestinal disorders | Tanezumab 10 mg | 8 | 295 | |
| other | Diarrhoea | Gastrointestinal disorders | Tanezumab 20 mg | 8 | 295 | |
| other | Diarrhoea | Gastrointestinal disorders | Naproxen 500 mg | 4 | 295 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 230 | |
| other | Nausea | Gastrointestinal disorders | Tanezumab 5 mg | 6 | 232 | |
| other | Nausea | Gastrointestinal disorders | Tanezumab 10 mg | 6 | 295 | |
| other | Nausea | Gastrointestinal disorders | Tanezumab 20 mg | 12 | 295 | |
| other | Nausea | Gastrointestinal disorders | Naproxen 500 mg | 9 | 295 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Tanezumab 5 mg | ||
| Total, all-cause mortality | Tanezumab 10 mg | ||
| Total, all-cause mortality | Tanezumab 20 mg | ||
| Total, all-cause mortality | Naproxen 500 mg | ||
| Total, other adverse events | Placebo | 74 | 230 |
| Total, other adverse events | Tanezumab 5 mg | 80 | 232 |
| Total, other adverse events | Tanezumab 10 mg | 114 | 295 |
| Total, other adverse events | Tanezumab 20 mg | 134 | 295 |
| Total, other adverse events | Naproxen 500 mg | 76 | 295 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
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