UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001460 |
|---|---|
| Receipt number | R000001776 |
| Scientific Title | The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome |
| Date of disclosure of the study information | 2008/10/29 |
| Last modified on | 2010/09/20 00:00:48 |
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Basic information
Public title
The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome
Acronym
Efficacy of pirocarpine for juvenile SS
Scientific Title
The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome
Scientific Title:Acronym
Efficacy of pirocarpine for juvenile SS
Region
| Japan |
Condition
Condition
Sjogren's syndrome
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with Sjogren's syndrome in pediatric age, there are not few cases whose salivary production decreases and needs pharmacological therapy. However, there is few drugs which has evidence of the efficacy and safety for this age group. Thus, in this study we will investigate the efficacy and safety of pilocarpine hydrochloride in pediatric SS patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of salivary production, change of pulse rate and blood pressure
Key secondary outcomes
Change of oral symptoms: oral abnormality, cracker sign, abnormal feeling of oral cavity at morning, mouth odor, total water intake, xerostomia.
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
Oral pilocarpine hydrochloride for 4 weeks.
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed as Sjogren's syndrome and met all of following inclusion criteria.
1) Patients who are 6~16 years of age and can provide the written informed consent.
2) Patients who have mouth abnormality including dryness of mouth
3) Patients who can discontinue use of any prohibited medication at least 14 days prior to admission to the study
4) Patients who can discontinue use of any medication requiring careful administration at least 14 days prior to admission to the study, if they discontinue them.
5) Patients who can be treated as outpatients throughout the study.
6) Patients who can undergo Saxon test.
Key exclusion criteria
Patients who fulfills any of following exclusion criteria will be excluded.
1) Secondary Sjogren's syndrome
2) Hypersensitivity to pilocarpine HCl or cevimeline HCl
3) Iritis
4) A condition predisposing to retinal detachment including having retinal breaks or history of retinal breaks
5) Serious gallbladder disease, biliary disease or biliary obstruction
6) Serious nephrolithiasis or ureterolithiasis
7) Bronchial asthma, chronic obstructive lung disease or interstitial pneumonia
8) Gastrointestinal obstruction or bladder neck obstruction
9) Epilepsy
10) Serious cardiac disease including ischemic heart disease, serious arrhythmia, cardiomyopathy or myocarditis
11) Serious vascular disease including aortic aneurysm, aortic dissection
12) Serious cerebrovascular disorder including brain hemorrhage after surgery, stroke, or aortic dissection
13) Serious hepatic disorder including fulminant hepatitis, hepatic cirrhosis, hepatic tumor or total bilirubin level 3.0mg/dL or higher or AST(GOT) or ALT(GPT) of at least 2.5 fold higher than the upper standard limit
14) Serious renal disease including nephritic syndrome, acute nephropathy, acute nephritis, chronic nephritis or serum creatinine level 1.5mg/dL or higher
15) Serious blood disease or hematopoietic system disorder
16) Patients who are considered ineligible for participation in the study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MINAKO TOMIITA |
Organization
Chiba University
Division name
Graduate School of Medicine, Department of Pediatrics
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-226-2144
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MINAKO TOMIITA |
Organization
Chiba University
Division name
Graduate School of Medicine, Department of Pediatrics
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
043-226-2144
Homepage URL
Sponsor or person
Institute
Department of Pediatrics, Graduate School of Medicine, Chiba Univerity
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 10 | Month | 29 | Day |
Last modified on
| 2010 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001776
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