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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029307
Receipt No. 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

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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
Email 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
Email wmachiko@pharm.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033502

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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