DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Orient Pharma Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sialorrhoea

Intervention: OC oral solution treatment A (Drug); OC oral solution treatment B (Drug); OC oral solution treatment C (Drug); OC oral solution treatment D (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Orient Pharma Co., Ltd.

Official(s) and/or principal investigator(s):
Aaron L Ellenbogen, DO, MPH, Principal Investigator, Affiliation: QUEST Research Institute
Chi-Tai Chang, PhD, Study Director, Affiliation: Orient Pharma Co., Ltd.


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from pre-dose in the amount of secreted saliva using cotton roll method and 8 hours post-dose

Secondary outcome:

Subjective Numeric Rating Scale of drooling severity and frequency

Pharmacokinetic parameters for clonidine, oxybutynin and N-desethyloxybutynin

Number of subjects with clinically significant laboratory assessment data as a measure of safety and tolerability

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.


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of Parkinson's Disease for at least 2 years

- Patients with a score of ≥2 on the salivation section of UPDRS, item 6

- Patients Hoehn and Yahr stage must be ≤4

- under stable anti-Parkinson therapy throughout the study

- Able and willing to comply with the study procedures

- Able to provide and provision of a written informed consent

Exclusion Criteria:

- Female who is pregnant/lactating or planning to be pregnant

- Must not have a form of drug-induced or atypical parkinsonism or parkinsonism with

swallow problems due to other etiology

- Have current uncontrolled hypertension, symptomatic postural hypotension, active

Raynaud's disease or other peripheral vascular occlusive disease

- Have a history or presence of hyperthyroidism, congestive heart failure, coronary

heart disease, cardiac arrhythmias, tachycardia or severe bradycardia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree

- Have a history of narrow angle glaucoma or shallow anterior chamber

- Have a history or presence of gastrointestinal obstruction, including paralytic ileus

and intestinal atony or gastrointestinal motility disorders, toxic megacolon or severe ulcerative colitis

- Have a history or presence of bladder outflow obstruction or urinary retention

- Patients with hepatic or renal impairment

- Male with QTc > 430 ms or female with QTc > 450 ms ECG results at screening

- Concomitant use of α2-agonist, anticholinergic medication or other medications that

affect ACh levels

- Have a history of alcohol or substance abuse

- Any condition, including the presence of laboratory abnormalities, which places the

patient at unacceptable risk to participate in the study or confounds the ability to interpret data from the study

- Have a history of hypersensitivity to the investigational medicinal product or any of

the excipients or to medicinal products with similar chemical structures

- Have received treatment with any other investigational medicinal product in the last

6 weeks before administration of the first dose in this clinical study

- Have received treatment with any medicinal product known to have a well-defined

potential for toxicity to a major organ in the previous 3 months

- Have a positive result of the human immunodeficiency virus (HIV) 1 and 2 test

- Have problems to understand the protocol requirements, instructions and study related

restrictions, the nature, scope and possible consequences of the clinical study

- Are unlikely to comply with the protocol requirements, instructions and study related


- Patient is the Investigator or any sub-investigator, research assistant, pharmacist,

study coordinator, other staff or relative thereof directly involved in the conduct of the clinical study

- Vulnerable subjects

- Have any concurrent disease or condition that, in the opinion of the Investigator,

would make the patient unsuitable for participation in the clinical study

- Donation of 500 ml or more of blood within the last 8 weeks before start of the study

and for at least 4 weeks after study completion

- Have previously been enrolled in this clinical study

- Vulnerable subjects

Locations and Contacts

QUEST Research Institute, Bingham Farms, Michigan 48025, United States
Additional Information

Starting date: August 2011
Last updated: June 14, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017