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NCT00337402 Clinical Trial

Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00337402
Other study ID # CHU63-0001
Secondary ID
Status Completed
Phase N/A
First received June 15, 2006
Last updated November 20, 2006
Start date January 2002
Est. completion date June 2005

Study information
Verified date June 2006
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Description:

Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy

Recruitment information / eligibility
Status Completed
Enrollment 380
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients > 18 years-old

- ALS certain or probable

- vital capacity (respiratory) > 70 %

- under riluzole

Exclusion Criteria:

- ALS in family

- other conditions affected survival and QoL

- cognitive impairment

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
France Clermont-Ferrand University Hospital Clermont-Ferrand

Sponsors (16)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Nice, Neurological department of Lyon University Hospital, University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, University Hospital, Marseille, University Hospital, Montpellier, University Hospital, Paris, University Hospital, Strasbourg, University Hospital, Toulouse, University Hospital, Tours

Country where clinical trial is conducted

France, 

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