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

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 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


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

Value
https://center6.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