A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01370811|
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 17, 2013
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01370811
|United States, Michigan|
|QUEST Research Institute|
|Bingham Farms, Michigan, United States, 48025|
|Principal Investigator:||Aaron L Ellenbogen, DO, MPH||QUEST Research Institute|
|Study Director:||Chi-Tai Chang, PhD||Orient Pharma Co., Ltd.|