UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients
Title of the study (Brief title)	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	Yoshinori Komagata
Organization	Teikyo University
Division name	School of Medicine
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	Machiko Watanabe
Organization	Teikyo University
Division name	Faculty of Pharma-Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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