Trial · NCT00876187
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16 | Baseline, Week 8, 16 | ITT analysis set. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | percentage of impairment | MEAN |
| SECONDARY | Percentage of Participants Who Used Rescue Medications | Week 2, 4, 8, 12, 16 | ITT analysis set. LOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. | percentage of participants | NUMBER |
| SECONDARY | Duration of Rescue Medication Use | Week 2, 4, 8, 12, 16 | ITT analysis set. LOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. | days/week | MEDIAN |
| SECONDARY | Amount of Rescue Medication Taken | Week 2, 4, 8, 12, 16 | ITT analysis set. LOCF method was used to impute missing values. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. | mg per week | MEAN |
| SECONDARY | Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24 | Baseline, Week 8, 16, 24 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. Here 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Developed Anti-Tanezumab Antibodies | Baseline (Day 1), Week 8, 16, 24 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration of Tanezumab | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. 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 | nanogram per milliliter | MEAN |
| SECONDARY | Total Nerve Growth Factor (NGF) Concentration | Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. 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 | picogram per mL | MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 24 | ITT analysis set included all participants who received at least 1 dose of intravenous study medication. | Participants | COUNT_OF_PARTICIPANTS |
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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