Trial · NCT01229436
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Passive Extension Deficit (TPED) at Baseline for First Injection | Baseline for first injection | Full analysis set(FAS):participants who received at least (\>=)1 injection of Xiapex,had \>=1 post-injection efficacy assessment(goniometric/participant-reported). 'N'(number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection | Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection | FAS population. 'N' (number of participants analyzed) includes total number of participants in FAS,however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. Here, 'n' signifies number of fingers/joints evaluable for this outcome measure at given time points. | degrees | MEDIAN |
| SECONDARY | Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints | Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| SECONDARY | Participant Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection | FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points. | participants | NUMBER |
| SECONDARY | Physician Global Assessment of Treatment Satisfaction and Disease Severity | Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection | FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points. | participants | NUMBER |
| SECONDARY | Number of Participants With Type of Concomitant Pain Medication Used | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Laboratory Abnormalities | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Anti-Drug Antibody (ADA) | Screening, Follow-up Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. | participants | NUMBER |
| SECONDARY | Number of Days of Concomitant Pain Medication Usage | Screening up to Day 180 after last injection | Safety set included all participants who received at least 1 injection of Xiapex. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. | days | MEDIAN |
| SECONDARY | Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire | C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30 | FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. | days | MEDIAN |
| SECONDARY | Time to Recovery | Up to Day 30 after first, second and third injection | FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. | days | MEDIAN |
| SECONDARY | Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score | Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection | FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. | units on a scale | MEDIAN |
| SECONDARY | Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection | FAS: participants who received \>= 1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'n' signifies those participants who were evaluable for this measure at given time points. | participants | NUMBER |
| SECONDARY | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection | FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of events was not analyzed for participants who responded that they did not perform the event. | events | MEDIAN |
| SECONDARY | Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire | Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection | FAS population. 'Number of participants' analyzed signifies those participants who were evaluable for this outcome measure. 'n' signifies those participants who were evaluable for this measure at given time points. Data for number of days was not analyzed for participants who responded that they did not perform the event. | days | MEDIAN |
| PRIMARY | Total Passive Extension Deficit (TPED) at Baseline for Second Injection | Baseline for second injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
| PRIMARY | Total Passive Extension Deficit (TPED) at Baseline for Third Injection | Baseline for third injection | FAS: participants who received \>=1 injection of Xiapex, had \>=1 post-injection efficacy assessment, whether goniometric or participant-reported. 'N' (number of participants analyzed) includes total number of participants in FAS, however actual 'N' for this outcome is unknown as these data were not calculated as per planned analysis. | degrees | MEDIAN |
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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