Phase 3
N=254
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
Dupuytren's Contracture
Bottom Line
View on ClinicalTrials.gov: NCT01229436 ↗Enrolled (actual)
254
Serious AEs
4.7%
Results posted
Mar 2014
Primary outcome: Primary: Total Passive Extension Deficit (TPED) at Baseline for First Injection — 55.0 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Xiapex (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Passive Extension Deficit (TPED) at Baseline for First Injection |
55.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Baseline for Second Injection |
45.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Baseline for Third Injection |
40.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection |
20.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 1 After First Injection |
20.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 7 After First Injection |
10.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 30 After First Injection |
10.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 1 After Second Injection |
29.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 7 After Second Injection |
20.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 30 After Second Injection |
20.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 1 After Third Injection |
15.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 7 After Third Injection |
22.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 30 After Third Injection |
30.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection |
0.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection |
0.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection |
10.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 90 After Last Injection |
10.0 | — |
| PRIMARY Total Passive Extension Deficit (TPED) at Day 180 After Last Injection |
14.5 | — |
| SECONDARY Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints |
40.0; 8.0; 0.0; 0.0; 25.0; 5.0 | — |
| 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 |
-31.0; -40.0; -40.0; -20.0; -20.0; -20.0 | — |
| 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 |
-30.0; -30.0; -35.0; -20.0; -20.0; -20.0 | — |
| SECONDARY Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints |
45.0; 65.0; 80.0; 86.0; 60.0; 76.0 | — |
| SECONDARY Participant Global Assessment of Treatment Satisfaction and Disease Severity |
2; 40; 128; 84; 63; 114 | — |
| SECONDARY Physician Global Assessment of Treatment Satisfaction and Disease Severity |
51; 138; 65; 60; 106; 62 | — |
| SECONDARY Number of Participants With Type of Concomitant Pain Medication Used |
5; 2; 1; 1; 1; 3 | — |
| SECONDARY Number of Days of Concomitant Pain Medication Usage |
2.0 | — |
| SECONDARY Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire |
3.0; 2.0; 2.0; 5.0; 12.0; 3.0 | — |
| SECONDARY Time to Recovery |
3.0; 4.0; 3.0 | — |
| SECONDARY Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score |
13.0; 3.0; 7.0; 4.0; 8.0; 3.0 | — |
| SECONDARY Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire |
10; 0; 1; 2; 0; 2 | — |
| SECONDARY Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire |
1.0; 2.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire |
8.0; 2.0; 2.0; 8.5; 20.0; 8.0 | — |
Summary
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).
Eligibility Criteria
Inclusion Criteria
- Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
- Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Exclusion Criteria
- Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
- On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
- Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
Data sourced from ClinicalTrials.gov (NCT01229436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.