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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2016 |
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Main ID: |
NCT02405598 |
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Date of registration:
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22/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Salbutamol as an Adjuvant Therapy for Pompe Disease
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Scientific title:
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Evaluation of Salbutamol as an Adjuvant Therapy for Pompe Disease |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02405598 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Yin-Hsiu Chien, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Confirm diagnosis as Pompe disease
2. age 2 years or above
3. under at least 1 year regular recombinant human acid alpha glucosidase, and no
dosage/frequency change in recent 3 months
4. Provide inform consent
Exclusion Criteria:
1. chronic heart disease such as arrhythmia, cardiomyopathy, cardiac infarction
2. history of seizure
3. history of diabetes mellitus
4. history of hyperthyroidism
5. hypokalemia
6. pregnant
7. allergy to ß-agonists
8. under medications including diuretics, digoxin, beta-blockers, etc
Age minimum:
2 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pompe Disease
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Intervention(s)
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Drug: Salbutamol
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Primary Outcome(s)
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10% decrement of creatinine kinase
[Time Frame: 6 months]
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Improvement in 6-minutes walk test
[Time Frame: 6 months]
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Secondary ID(s)
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201308031MINC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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