Unique ID issued by UMIN | UMIN000011494 |
---|---|
Receipt number | R000013085 |
Scientific Title | Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling |
Date of disclosure of the study information | 2013/09/02 |
Last modified on | 2016/06/19 15:58:37 |
Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling
SCOPOLA-D
Assessment of the efficacy and the influence on swallowing function of transdermal scopolamine for ALS patinets' drooling
SCOPOLA-D
Japan |
amyotrophic lateral sclerosis
Neurology |
Malignancy
NO
To assess the efficacies of transdermal scopolamine for the reduction of saliva and drooing of ALS patients comparing with placebo.We'll also check the swallowing dysfunction and aspiration pneumonias after using the scopolamine pathces.We'd like to confirm the fair usage of scopolamine pathces.
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Efficacy of transdermal scopolamine for ALS patients' drooling assessed by VAS(visual analogue scale) and SSS(sialorrhea scoring scale).
Efficacy of transdermal scopolamine for ALS patients' drooling assessed by other scales besides VAS and SSS.
Influences on the swallowing dysfunction worthning.
Adverse ivents.
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
scopolamine patch 7days-washout 7days-placebo patch 7days
placebo patch 7days-washout 7days-scopolamine patch 7days
Not applicable |
Not applicable |
Male and Female
1.ALS patients with drooling
who were diagnosed by EI Escorial revised Airlie House criteria as clinically definite,clinically probable or clinically pssible ALS.
2.The patients who consented to commit to this research in writing after sufficient informed consent
1.diagnosed as progressive case
delta FS is over 0.67
2.diagnosed as severe hypoventilation and the patient doesn't want to use NIPPV
3.diagnosed as glaucoma
4.diagnosed as benign prostatic hypertrophy
5.past history of intestinal obstruction
6.allergy to this drug
7.pregnant or expecting to be pregnant
8.judged as an inadequate patient by responsible doctors
10
1st name | |
Middle name | |
Last name | Yugo Narita |
Mie University Faculty of medicine
school of nursing
2-174 Edobashi Tsu, Mie 514-8507, Japan
059-232-1111
yug@clin.medic.mie-u.ac.jp
1st name | |
Middle name | |
Last name | Yugo Narita |
Mie University graduate school of medicine
Department of neurology
2-174 Edobashi Tsu, Mie 514-8507, Japan
059-232-1111
yug@clin.medic.mie-u.ac.jp
Mie University Graduate school of medicine,Department of neurology
Group which MHLW(Ministry of health,labor and welfare)pays subsidies for the reserches of medical improvement and supports for the patients with intractable diseases
Japanese Governmental office
Japan
Matsusaka Chuou Hospital
National Mie Hospital
NO
三重大学医学部付属病院(三重県)、松阪中央総合病院(三重県)、独立行政法人国立病院機構三重病院
2013 | Year | 09 | Month | 02 | Day |
Unpublished
2013.11.5. first case was started
2013.11.7. first case was stopped
2014.5.2. We corrected the protocol and involved other two hospitals.
2014.7.9. the second case was started.
2014.8.6. the second case was completed.
2014.9.9. the3rd-5th cases were started.
2014.10.7.the3rd-5th cases were started.
2015.11. the 6th-10th cases were completed.
Completed
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 09 | Month | 02 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 07 | Month | 31 | Day |
We involved other two hospitals,Mie hospital and Kinan hospital.
2013 | Year | 08 | Month | 15 | Day |
2016 | Year | 06 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013085
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |