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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01370811
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 17, 2013
Information provided by (Responsible Party):
Orient Pharma Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Sialorrhoea Drug: OC oral solution treatment A Drug: OC oral solution treatment B Drug: OC oral solution treatment C Drug: OC oral solution treatment D Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: OC oral solution treatment D
Drug: OC oral solution treatment D
Other Name: Placebo
Experimental: OC oral solution treatment C
High dose oxybutynin and clonidine
Drug: OC oral solution treatment C
Other Name: OP-014
Experimental: OC oral solution treatment A
Low dose oxybutynin and clonidine
Drug: OC oral solution treatment A
Other Name: OP-014
Experimental: OC oral solution treatment B
Intermediate dose oxybutynin and clonidine
Drug: OC oral solution treatment B
Other Name: OP-014

Primary Outcome Measures :
  1. Change from pre-dose in the amount of secreted saliva using cotton roll method and 8 hours post-dose [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 7, 8 hours post-dose ]
    Nine measurements of the amount (weight) of mixed salivary secretions using cotton rolls will be carried out prior and after the administration of the study drug in every study treatment (Treatment A~D).

Secondary Outcome Measures :
  1. Subjective Numeric Rating Scale of drooling severity and frequency [ Time Frame: Pre-dose and 8 hours post-dose ]
  2. Pharmacokinetic parameters for clonidine, oxybutynin and N-desethyloxybutynin [ Time Frame: 0, 0.25, 0.5, 0.75, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 hours post-dose ]
    Pharmacokinetic parameters include Cmax, tmax, AUC0-t,Cl,Vd, Lambda z and t1/2. Eleven PK samples to be collected from pre-dose(0), 0.25, 0.5, 0.75, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0 hours post-dose in every study treatment (Treatment A~D).

  3. Number of subjects with clinically significant laboratory assessment data as a measure of safety and tolerability [ Time Frame: at least 23 days ]

    Hematology: Erythrocytes, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) neutrophils, eosinophils, basophils, lymphocytes, monocytes, leukocytes and platelets.

    Clinical chemistry: Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase.

    Urinalysis: pH, protein, glucose, ketone, bilirubin, blood, nitrite and sediment, if necessary.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 restrictions
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01370811

United States, Michigan
QUEST Research Institute
Bingham Farms, Michigan, United States, 48025
Sponsors and Collaborators
Orient Pharma Co., Ltd.
Principal Investigator: Aaron L Ellenbogen, DO, MPH QUEST Research Institute
Study Director: Chi-Tai Chang, PhD Orient Pharma Co., Ltd.

Responsible Party: Orient Pharma Co., Ltd. Identifier: NCT01370811     History of Changes
Other Study ID Numbers: OP-014-201
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by Orient Pharma Co., Ltd.:
OC Oral Solution
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists