Trial · NCT00830063
Tanezumab In Osteoarthritis Of The Knee (2)
NCT00830063, Phase 3, Completed, Pfizer; results first posted 2021-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tanezumab In Osteoarthritis Of The Knee (2). Trials, record NCT00830063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00830063
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tanezumab In Osteoarthritis Of The Knee (2)
- NCT number
- NCT00830063
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 832 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Arthritis, Osteoarthritis
- Interventions
- tanezumab 10 mg, tanezumab 5 mg, naproxen, placebo
- First posted
- 2009-01-27
- Last updated
- 2021-05-13
- Results first posted
- 2021-05-13
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline (Day 1), Week 16 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. |
| Primary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Primary | Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) | Baseline, Week 2, 4, 8, 12 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) | Baseline, Week 2, 4, 8, 12 | WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Secondary | Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. |
| Secondary | Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) | Baseline, Week 2, 4, 8, 12 | Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. |
| Secondary | Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF) | Weeks 2, 4, 8, 12, 16 | A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 \[minimum affected\] to 5 \[maximum affected\], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline (Day 1), Week 16 | Modified ITT (mITT): All participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here Overall number of participants analyzed (N) signifies the participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here 'N' signifies the participants evaluable for this outcome measure. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) | Baseline, Week 2, 4, 8, 12 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) | Baseline, Week 2, 4, 8, 12 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF) | Baseline, Week 2, 4, 8, 12 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF) | Baseline, Week 2, 4, 8, 12 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure. | units on a scale | MEAN |
| SECONDARY | Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF) | Weeks 2, 4, 8, 12, 16 | mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. | percentage of participants | NUMBER |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group1,016
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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Placebo | Baseline | 7.21 | Standard Deviation 1.43 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 5 mg + Placebo | Baseline | 7.30 | Standard Deviation 1.47 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 10 mg + Placebo | Baseline | 7.25 | Standard Deviation 1.41 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Naproxen + Placebo | Baseline | 7.18 | Standard Deviation 1.37 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Placebo | Change at Week 16 | -2.23 | Standard Deviation 2.56 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 5 mg + Placebo | Change at Week 16 | -3.55 | Standard Deviation 2.84 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 10 mg + Placebo | Change at Week 16 | -3.27 | Standard Deviation 2.81 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Naproxen + Placebo | Change at Week 16 | -2.82 | Standard Deviation 2.54 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Placebo | Baseline | 6.85 | Standard Deviation 1.56 | units on a scale |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF) | Tanezumab 5 mg + Placebo | Baseline | 6.86 | Standard Deviation 1.71 | units on a scale |
1 to 10 of 1,016Source ClinicalTrials.gov
See all 1,016 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 208 | |
| Overall Study | STARTED | Tanezumab 5 mg + Placebo | 208 | |
| Overall Study | STARTED | Tanezumab 10 mg + Placebo | 208 | |
| Overall Study | STARTED | Naproxen + Placebo | 208 | |
| Overall Study | Treated | Placebo | 208 | |
| Overall Study | Treated | Tanezumab 5 mg + Placebo | 206 | |
| Overall Study | Treated | Tanezumab 10 mg + Placebo | 208 | |
| Overall Study | Treated | Naproxen + Placebo | 206 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Tanezumab 5 mg + Placebo | 16 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events248
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 | 0 | 208 | |
| other | Constipation | Gastrointestinal disorders | Tanezumab 5 mg + Placebo | 1 | 206 | |
| other | Constipation | Gastrointestinal disorders | Tanezumab 10 mg + Placebo | 1 | 208 | |
| other | Constipation | Gastrointestinal disorders | Naproxen + Placebo | 6 | 206 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 208 | |
| other | Nausea | Gastrointestinal disorders | Tanezumab 5 mg + Placebo | 4 | 206 | |
| other | Nausea | Gastrointestinal disorders | Tanezumab 10 mg + Placebo | 4 | 208 | |
| other | Nausea | Gastrointestinal disorders | Naproxen + Placebo | 6 | 206 | |
| other | Oedema peripheral | General disorders | Placebo | 0 | 208 | |
| other | Oedema peripheral | General disorders | Tanezumab 5 mg + Placebo | 9 | 206 |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 adverse eventsAdverse event totals12
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 + Placebo | ||
| Total, all-cause mortality | Tanezumab 10 mg + Placebo | ||
| Total, all-cause mortality | Naproxen + Placebo | ||
| Total, other adverse events | Placebo | 59 | 208 |
| Total, other adverse events | Tanezumab 5 mg + Placebo | 70 | 206 |
| Total, other adverse events | Tanezumab 10 mg + Placebo | 92 | 208 |
| Total, other adverse events | Naproxen + Placebo | 68 | 206 |
| Total, serious adverse events | Placebo | 8 | 208 |
| Total, serious adverse events | Tanezumab 5 mg + Placebo | 7 | 206 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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
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