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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Sia

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.

Detailed Summary: 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.
Sponsor: Orient Pharma Co., Ltd.

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjective Numeric Rating Scale of drooling severity and frequency [ Time Frame: Pre-dose and 8 hours post-dose ]
  • 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).
  • 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.



Original Secondary Outcome: Same as current

Information By: Orient Pharma Co., Ltd.

Dates:
Date Received: June 8, 2011
Date Started: August 2011
Date Completion:
Last Updated: June 14, 2013
Last Verified: June 2013