SialorrhoeaPhase 2NCT01370811
A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
A Phase 2 study testing oxybutynin and clonidine oral solution treatment A, oxybutynin and clonidine oral solution treatment B and oxybutynin and clonidine oral solution treatment C in people with Sialorrhoea, run by Orient Pharma Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Sialorrhoea
- What is being tested?
- oxybutynin and clonidine oral solution treatment A, oxybutynin and clonidine oral solution treatment B and oxybutynin and clonidine oral solution treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
QUEST Research Institute
Bingham Farms, Michigan, 48025
About this study
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
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.
Read the 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.
- Conditions
- Sialorrhoea
- Being tested
- oxybutynin and clonidine oral solution treatment A, oxybutynin and clonidine oral solution treatment B, oxybutynin and clonidine oral solution treatment C, oxybutynin and clonidine oral solution treatment D
- Keywords
- oxybutynin, clonidine, OC Oral Solution, sialorrhoea, Parkinson's disease
- Medical subject headings
- Sialorrhea, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxybutynin and clonidine oral solution treatment ADrug
Also called OP-014
oxybutynin and clonidine oral solution treatment BDrug
Also called OP-014
oxybutynin and clonidine oral solution treatment CDrug
Also called OP-014
oxybutynin and clonidine oral solution treatment DDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| oxybutynin and clonidine oral solution treatment D | Placebo comparator | Placebo Receives: Drug: oxybutynin and clonidine oral solution treatment D |
| oxybutynin and clonidine oral solution treatment C | Experimental | High dose oxybutynin and clonidine Receives: Drug: oxybutynin and clonidine oral solution treatment C |
| oxybutynin and clonidine oral solution treatment A | Experimental | Low dose oxybutynin and clonidine Receives: Drug: oxybutynin and clonidine oral solution treatment A |
| oxybutynin and clonidine oral solution treatment B | Experimental | Intermediate dose oxybutynin and clonidine Receives: Drug: oxybutynin and clonidine oral solution treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva Secreted Rate
Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
Measured: 8 hours post-dose
Secondary outcomes (2)
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.
Measured: 8 hours post-dose
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.
Measured: during the study treatment period and follow up period at least 23 days excluding the screening period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SialorrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orient Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron L Ellenbogen, DO, MPH, Principal investigator, QUEST Research InstituteChi-Tai Chang, PhD, Study director, Orient Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370811
- Sponsor's protocol ID
- OP-014-201
- Status last verified
- Mar 2023
- First submitted
- 8 Jun 2011
- Last updated
- 10 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01370811
- Acronym / sponsor ID
- OP-014-201
- Conditions
- Sialorrhoea
- Keywords
- oxybutynin, clonidine, OC Oral Solution, sialorrhoea, Parkinson's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Orient Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Posted 10 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| oxybutynin and clonidine oral solution treatment D | Placebo comparator | Drug: oxybutynin and clonidine oral solution treatment DPlacebo |
| oxybutynin and clonidine oral solution treatment C | Experimental | Drug: oxybutynin and clonidine oral solution treatment CHigh dose oxybutynin and clonidine |
| oxybutynin and clonidine oral solution treatment A | Experimental | Drug: oxybutynin and clonidine oral solution treatment ALow dose oxybutynin and clonidine |
| oxybutynin and clonidine oral solution treatment B | Experimental | Drug: oxybutynin and clonidine oral solution treatment BIntermediate dose oxybutynin and clonidine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxybutynin and clonidine oral solution treatment AAlso: OP-014 | Drug | oxybutynin and clonidine oral solution treatment A |
| oxybutynin and clonidine oral solution treatment BAlso: OP-014 | Drug | oxybutynin and clonidine oral solution treatment B |
| oxybutynin and clonidine oral solution treatment CAlso: OP-014 | Drug | oxybutynin and clonidine oral solution treatment C |
| oxybutynin and clonidine oral solution treatment DAlso: PlaceboPlacebo | Drug | oxybutynin and clonidine oral solution treatment D |
Primary outcome
Saliva Secreted Rate
Time frame: 8 hours post-dose
Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
2 secondary outcomes
Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production
Time frame: 8 hours post-dose
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
Time frame: during the study treatment period and follow up period at least 23 days excluding the screening period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sialorrhoea
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Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
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Application of Neuro-electrostimulation as a Treatment for Patients With Dry Mouth
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Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
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Effect of SCS Technique on Oromotor Skills in Children With CP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron L Ellenbogen, DO, MPH principal investigator
QUEST Research Institute
Chi-Tai Chang, PhD study director
Orient Pharma Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxybutynin and clonidine oral solution treatment A, oxybutynin and clonidine oral solution treatment B and oxybutynin and clonidine oral solution treatment C in people with Sialorrhoea, run by Orient Pharma Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva Secreted Rate (time frame: 8 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.