Trial Outcomes & Findings for Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb (NCT NCT01265420)
NCT ID: NCT01265420
Last Updated: 2015-04-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
30 days after last injection
Results posted on
2015-04-30
Participant Flow
Participant milestones
| Measure |
Injectable Clostridial Collagenase
Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Injectable Clostridial Collagenase
Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Baseline characteristics by cohort
| Measure |
Injectable Clostridial Collagenase
n=7 Participants
Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after last injectionOutcome measures
| Measure |
Injectable Clostridial Collagenase
n=6 Participants
Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
|
|---|---|
|
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
>50% reduction in contracture
|
5 participants
|
|
Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
<50% reduction in contracture
|
1 participants
|
Adverse Events
Injectable Clostridial Collagenase
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Injectable Clostridial Collagenase
n=7 participants at risk
Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
|
|---|---|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
100.0%
7/7 • Day 1 after injection to Day 30
|
|
Skin and subcutaneous tissue disorders
Edema
|
100.0%
7/7 • Day 1 after injection to Day 30
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
14.3%
1/7 • Day 1 after injection to Day 30
|
|
Nervous system disorders
Paresthesia
|
14.3%
1/7 • Day 1 after injection to Day 30
|
|
Gastrointestinal disorders
nausea
|
14.3%
1/7 • Day 1 after injection to Day 30
|
|
Skin and subcutaneous tissue disorders
Skin Tear
|
14.3%
1/7 • Day 1 after injection to Day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place