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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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19 February 2015 |
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Main ID: |
NCT00296621 |
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Date of registration:
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23/02/2006 |
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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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Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy
MDB-GLN |
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Scientific title:
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Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00296621 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Régis Hankard, 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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Centre Hospitalier Universitaire (CHU) de Poitiers |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of Duchenne muscular dystrophy
- Able to walk >170 m
- Absence of hepatic insufficiency
- Absence of renal insufficiency
Exclusion Criteria:
- Dependent upon wheelchair
- Body weight >60kg
- Liver failure
- Kidney failure
- Surgery scheduled during the year following the first visit
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Muscular Dystrophy, Duchenne
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Intervention(s)
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Drug: L-Glutamine
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Drug: placebo
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Primary Outcome(s)
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walking speed at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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Secondary Outcome(s)
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indices of protein degradation (CPK and 3-methyl histidine excretion) at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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2-minute walk test at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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muscle mass (24-h urinary creatinine excretion) at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BP3) at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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body composition (BIPHOTONIC absorptiometry) at 4,9 months
[Time Frame: at 4,9 months]
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work (kcal) at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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power (kcal/s) at 0,2,4,5,7,9 months
[Time Frame: at 0,2,4,5,7,9 months]
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Secondary ID(s)
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P030420
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AOM 03 121
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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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