Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 6/3/2018 |
| Start Date: | November 2013 |
| End Date: | January 2017 |
A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® (Part A) Followed by Open-Label, Multiple-Treatment With MYOBLOC® (Part B) in the Treatment of Troublesome Sialorrhea in Adult Subjects
This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea
(drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected
directly into the salivary glands. MYOBLOC has been shown in previous trials to safely
decrease saliva production, thereby demonstrating its potential as a safe and effective
treatment for troublesome sialorrhea.
(drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected
directly into the salivary glands. MYOBLOC has been shown in previous trials to safely
decrease saliva production, thereby demonstrating its potential as a safe and effective
treatment for troublesome sialorrhea.
Inclusion Criteria:
- Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring
secondary to any disorder or related to any cause
- Investigator sites will review entire list of inclusion criteria with potential
subjects
Exclusion Criteria:
- Any known prior exposure to botulinum toxin type B, or known adverse reaction or
sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC
solution components.
- Prior botulinum toxin treatment to the salivary glands at any time
- Investigator sites will review entire list of exclusion criteria with potential
subjects
We found this trial at
25
sites
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13 ulitsa Shiryamova
Irkutsk, Irkutsk Region 66407
Irkutsk, Irkutsk Region 66407
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