NCT01370811

A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease

A Phase II, Double-blind, Randomized, Placebo-controlled 4-way Crossover Study to Evaluate the Relative Efficacy and Safety of OC Oral Solution (Oxybutynin and Clonidine) for Sialorrhoea in Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Orient Pharma Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether OC (oxybutynin and clonidine) oral solution is effective in reducing saliva secretion in patients suffering from Parkinson's Disease with excessive salivation.

Detailed description

Sialorrhea is excessive flow of saliva associated with its unintentional loss from the mouth, commonly known as drooling. Sialorrhea may result from any combination of hypersecretion, problems swallowing or sensorimotor problems containing saliva in the mouth. It is commonly found in people with neurological dysfunction such as Parkinson's Disease, leading to social isolation and embarrassment. In general, treatment options are limited because of the underlying chronic disease. The objective of the proposed low-dose, new combination drug, OC Oral solution is to develop a new treatment option that can be used to titrate saliva secretion rates to a level that is low enough to prevent unintentional loss (i.e. drooling) but not so low as to cause an uncomfortably dry mouth.

Conditions

• Sialorrhoea

Interventions

Type	Name	Description
DRUG	oxybutynin and clonidine oral solution treatment A
DRUG	oxybutynin and clonidine oral solution treatment B
DRUG	oxybutynin and clonidine oral solution treatment C
DRUG	oxybutynin and clonidine oral solution treatment D	Placebo

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-06-10
• Last updated: 2023-04-10
• Results posted: 2023-04-10

Locations

1 site across 1 country: United States