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Trial · NCT04385303

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12Baseline and Week 12Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24Baseline and Week 24Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12Baseline and Week 12Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24Baseline and Week 24Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12Baseline and Week 12Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.units on a scaleMEAN
SECONDARYChange From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24Baseline and Week 24Full Analysis Set includes all subjects who were randomized and received a study injection. Subjects' observed data were analyzed as randomized without imputation.units on a scaleLEAST_SQUARES_MEAN
POST_HOCChange From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12 in Subjects With Kellgren-Lawrence Grade 2Baseline and Week 12
The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
units on a scaleLEAST_SQUARES_MEAN
POST_HOCChange From Baseline OA Pain in the Target Knee as Assessed by the Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 24 in Subjects With Kellgren-Lawrence Grade 2Baseline and Week 24
The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
units on a scaleLEAST_SQUARES_MEAN
POST_HOC
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12 in Subjects With Kellgren-Lawrence Grade 2
Baseline and Week 12
The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
units on a scaleLEAST_SQUARES_MEAN
POST_HOC
Change From Baseline OA Function in the Target Knee as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 24 in Subjects With Kellgren-Lawrence Grade 2
Baseline and Week 24
The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
units on a scaleLEAST_SQUARES_MEAN
POST_HOCChange From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12 in Subjects With Kellgren-Lawrence Grade 2Baseline and Week 12
The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.)
units on a scaleMEAN
POST_HOCChange From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 24 in Subjects With Kellgren-Lawrence Grade 2Baseline and Week 24
The Per-Protocol Analysis Set (PPAS) includes FAS subjects who received the correct treatment, completed the study, and did not have any protocol deviations that might impact the evaluation of efficacy outcomes. Kellgren-Lawrence Grade 2 only subjects' observed data were analyzed as randomized without imputation.
units on a scaleMEAN

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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GET https://conductscience.org/api/trials/v1/NCT04385303/outcomes