Sialorrhoea Clinical Trial
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
| Verified date | March 2023 |
| Source | Orient Pharma Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility | 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 a2-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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | QUEST Research Institute | Bingham Farms | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Orient Pharma Co., Ltd. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Saliva Secreted Rate | Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion. | 8 hours post-dose | |
| Secondary | Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | Evaluation of change from baseline the subjective assessment of saliva production after administration of a single dose of different combinations of oxybutynin and clonidine (OC Oral solution) in patients suffering from Parkinson's disease with excessive salivation. Compare with baseline the number of rate scale was more production with baseline or reduce from baseline.
The min and max of the score is 0 and 10, the total range is 0~10, and higher value is represented more worse outcome. |
8 hours post-dose | |
| Secondary | Evaluation of the Safety and Tolerability of Different Combinations of Oxybutynin and Clonidine (OC Oral Solution) in Patients Suffering From Parkinson's Disease With Excessive Salivation | Evaluation of the safety and tolerability of different combinations of oxybutynin and clonidine (OC Oral solution) in patients suffering from Parkinson's disease with excessive salivation. Calculate the treatment Emergent Adverse Events number during the study treatment period and follow up period up to at least 23 days excluding the screening period. | during the study treatment period and follow up period at least 23 days excluding the screening period. |