UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029307 |
|---|---|
| Receipt number | R000033502 |
| Scientific Title | Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients |
| Date of disclosure of the study information | 2017/09/27 |
| Last modified on | 2017/09/27 11:38:21 |
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Basic information
Public title
Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients
Acronym
Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients
Scientific Title
Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients
Scientific Title:Acronym
Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients
Region
| Japan |
Condition
Condition
Sjogren's syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at assessment of the efficacy and safety of a new pilocarpine / sodium alginate solution as a symptomatic treatment for dry mouth in Sjogren's syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary flow before and 60 minutes after administration
Key secondary outcomes
Subjective symptom of oral dryness
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as Sjogren's syndrome
2. Aged 16 years-old or more
3. With Salivary flow lower than 2 grams or less per 2 minutes
4. Having symptoms of oral dryness
5. Having submitted written informed consent
Key exclusion criteria
1. Patients with ischemic heart disease
2. Patients with asthma or chronic obstructive airway disease
3. Patients with gastrointestinal obstruction or bladder neck obstruction
4. Patients with epilepsy
5. Patients with parkinsonism or Parkinson's disease
6. Patients with iritis
7. Patients with hypersensitivity on pilocarpine or arginine
8. Patients administered with pilocarpine hydrochloride within 6.5 hours
9. Patients administered with cevimeline hydrochloride hydrate within 20 hours
10. Patients administered with anetholtrithion within 9.5 hours
11. Patients judged by a physician to be inappropriate for inclusion in the study for any other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Komagata |
Organization
Teikyo University
Division name
School of Medicine
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
03-3964-1211
komagata@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Machiko Watanabe |
Organization
Teikyo University
Division name
Faculty of Pharma-Science
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan
TEL
03-3964-1211
Homepage URL
wmachiko@pharm.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2017 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033502
