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Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000029307
Date of registration:	27/09/2017
Prospective Registration:	No
Primary sponsor:	Teikyo University
Public title:	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 - Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients
Date of first enrolment:	2009/02/01
Target sample size:	50
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033502
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Yoshinori Komagata
Address:	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan Japan
Telephone:	03-3964-1211
Email:	komagata@med.teikyo-u.ac.jp
Affiliation:	Teikyo University School of Medicine

Name:	Machiko Watanabe
Address:	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan Japan
Telephone:	03-3964-1211
Email:	wmachiko@pharm.teikyo-u.ac.jp
Affiliation:	Teikyo University Faculty of Pharma-Science

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 16years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Sjogren's syndrome

Intervention(s)

Pilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days.

Primary Outcome(s)

Salivary flow before and 60 minutes after administration

Secondary Outcome(s)

Subjective symptom of oral dryness Adverse events

Secondary ID(s)

Source(s) of Monetary Support

Teikyo University

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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