The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrate

UMIN ID: UMIN000000997

Registered date:28/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Xerostomia due to Sjogren`s syndrome
• Date of first enrollment: 2008/01/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

It is a gargle with a test drug(Cevimeline hydrochloride hydrate 30mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo1 (Cevimeline hydrochloride hydrate 9mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo2 (Hachiazule(TM)gargle2g+distilled water 50cc)for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out,It is a gargle with false placebo2 for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes.

Outcome(s)

• Primary Outcome: It is amount of increase in the unstimulated whole saliva secretion after gargle 90 minutes, gargle 60 minutes later, gargle 30 minutes later and gargle 15 minutes later.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude criteria: The person that a gargle is impossible. A person we have a history of sick treatment of facial nerve or is treating the present. A person we have a history of sick treatment of trigeminus or is treating the present. A person we have a history of salivary gland conditions treatment within six months before this agent administration start or is treating the present. A person of diabetes mellitus. A person having an extensive oral mucosa disorder. The person who took the medicine that it was thought that we had an influence on salivary secretion during taking again within examination one month. It is a hypersensitivity symptom and a person having contraindication in cevimeline hydrochloride hydrate and Hachiazule(TM) gargle. The pregnancy and a woman nursing or a woman with pregnant likelihood. In addition, the person who admitted that we were inappropriate though a study director performed the final examination.

Related Information

• Primary Sponsor: Department of Dentistry and Oral Surgery, Tochigi National Hospital
• Secondary Sponsor: National Institute of Public Health
• Source(s) of Monetary Support: None