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A Two-Part Study of BOTOX® Therapy for Ischemic Digits

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01309802
First received: March 4, 2011
Last updated: April 26, 2017
Last verified: April 2017
Results First Received: July 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Raynaud's Disease
Intervention: Drug: onabotulinum toxin type-A

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo no intervention
Onabotulinum Toxin Type-A

up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1

onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1


Participant Flow:   Overall Study
    Placebo   Onabotulinum Toxin Type-A
STARTED   25   23 
COMPLETED   13   14 
NOT COMPLETED   12   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo no intervention
Onabotulinum Toxin Type-A

up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1

onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1

Total Total of all reporting groups

Baseline Measures
   Placebo   Onabotulinum Toxin Type-A   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   23   48 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      23  92.0%      19  82.6%      42  87.5% 
>=65 years      2   8.0%      4  17.4%      6  12.5% 
Age 
[Units: Years]
Mean (Full Range)
 53.3 
 (24 to 73) 
 49.2 
 (26 to 70) 
 51.3 
 (24 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  84.0%      19  82.6%      40  83.3% 
Male      4  16.0%      4  17.4%      8  16.7% 
Region of Enrollment 
[Units: Participants]
     
United States   25   23   48 


  Outcome Measures
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1.  Primary:   Percentage of Patient Reported Pain-free Days   [ Time Frame: baseline to 28 days ]

2.  Secondary:   Quality of Life   [ Time Frame: change from baseline to 28 days ]

3.  Secondary:   Hand Function   [ Time Frame: baseline to 28 days ]

4.  Secondary:   Patient Satisfaction   [ Time Frame: baseline to 28 days ]

5.  Secondary:   Tissue Perfusion   [ Time Frame: baseline to 28 days ]

6.  Secondary:   EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal   [ Time Frame: baseline to 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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