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Trial record 1 of 2 for:    17255677 [PUBMED-IDS]
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A Two-Part Study of BOTOX® Therapy for Ischemic Digits

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ClinicalTrials.gov Identifier: NCT01309802
Recruitment Status : Active, not recruiting
First Posted : March 7, 2011
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Raynaud's Disease
Intervention Drug: onabotulinum toxin type-A
Enrollment 48

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description no intervention

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

Period Title: Overall Study
Started 25 23
Completed 13 14
Not Completed 12 9
Arm/Group Title Placebo Onabotulinum Toxin Type-A Total
Hide Arm/Group Description no intervention

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 of all reporting groups
Overall Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 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, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 23 participants 48 participants
53.3
(24 to 73)
49.2
(26 to 70)
51.3
(24 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
21
  84.0%
19
  82.6%
40
  83.3%
Male
4
  16.0%
4
  17.4%
8
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 23 participants 48 participants
25 23 48
1.Primary Outcome
Title Percentage of Patient Reported Pain-free Days
Hide Description Subjective pain scales [visual analogue scale (VAS) and faces pain assessment]. Subjects reporting total number of pain free days within the time period of 0-28 days.
Time Frame baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description:
no intervention

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

Overall Number of Participants Analyzed 25 23
Measure Type: Number
Unit of Measure: percentage of pain free days
12 48
2.Secondary Outcome
Title Quality of Life
Hide Description SF-12v2® Health Survey - Pain Enhanced
Time Frame change from baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected,
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description:
no intervention

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Hand Function
Hide Description Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure
Time Frame baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description:
no intervention

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Patient Satisfaction
Hide Description The Optum SF-12v2® Health Survey - A Short Patient Reported Survey Measuring Health Using Excellent, Very Good, Good, Fair and Poor Indicators. On a scale from Excellent to Poor, Excellent being the maximum outcome. Good is scored as average. Patient satisfaction assessed as the percentage of participants who responded; Excellent, Very Good and Good on the health survey on average feeling between baseline and 28 days.
Time Frame baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description:
no intervention

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

Overall Number of Participants Analyzed 25 23
Measure Type: Number
Unit of Measure: percentage of participants
12 48
5.Secondary Outcome
Title Tissue Perfusion
Hide Description Doppler perfusion imager and Periscan image analysis software
Time Frame baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description:
no intervention

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal
Hide Description A combined reported score measuring 5 dimensions; mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels; no problems, some problems, extreme problems
Time Frame baseline to 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
not were not collected
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description:
no intervention

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Onabotulinum Toxin Type-A
Hide Arm/Group Description no intervention

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

All-Cause Mortality
Placebo Onabotulinum Toxin Type-A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Onabotulinum Toxin Type-A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/25 (20.00%)      2/23 (8.70%)    
General disorders     
Throat Swelling *  1/25 (4.00%)  3 0/23 (0.00%)  0
Infections and infestations     
Infection *  2/25 (8.00%)  2 1/23 (4.35%)  1
Injury, poisoning and procedural complications     
Broken bone *  1/25 (4.00%)  1 0/23 (0.00%)  0
Dizziness *  1/25 (4.00%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Collapsed Lung *  0/25 (0.00%)  0 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Onabotulinum Toxin Type-A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/25 (100.00%)      22/23 (95.65%)    
Eye disorders     
Vision Changes *  0/25 (0.00%)  0 1/23 (4.35%)  1
Gastrointestinal disorders     
Nausea *  1/25 (4.00%)  1 1/23 (4.35%)  1
General disorders     
Pain, Redness, Bleeding *  14/25 (56.00%)  35 14/23 (60.87%)  31
Swelling, Tenderness, Bruising *  12/25 (48.00%)  17 7/23 (30.43%)  9
Dizziness, Drowsiness *  3/25 (12.00%)  3 3/23 (13.04%)  4
Dry Eyes, Dry Mouth *  1/25 (4.00%)  2 0/23 (0.00%) 
Increased Cough, Runny nose *  1/25 (4.00%)  2 0/23 (0.00%)  0
Allergic Reaction or Itching *  2/25 (8.00%)  2 0/23 (0.00%)  0
Tingling *  0/25 (0.00%)  0 1/23 (4.35%)  1
Shortness of breath *  1/25 (4.00%)  1 2/23 (8.70%)  2
Difficulty Swallowing *  2/25 (8.00%)  2 0/23 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Temporary Weakness or numbness of muscle *  16/25 (64.00%)  32 11/23 (47.83%)  20
*
Indicates events were collected by non-systematic assessment