CompletedNCT01370811Updated Apr 10, 2023Results posted

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

A Phase 2 interventional study of oxybutynin and clonidine oral solution treatment A and oxybutynin and clonidine oral solution treatment B in Sialorrhoea, sponsored by Orient Pharma Co., Ltd.. Completed at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-10.

Sponsored by Orient Pharma Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study 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 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 studied

Sialorrhoea

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Keywords

oxybutynin
clonidine
OC Oral Solution
sialorrhoea
Parkinson's disease

In context

Sialorrhea

60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.

This study's enrollment of 24 is below the median of 31 across 44 interventional studies indexed under Sialorrhea.

Browse Sialorrhea studies →

Lead sponsor

Orient Pharma Co., Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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 > 430 ms or female with QTc > 450 ms 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 to the medicinal product or any of the 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 (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

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 24 participants (actual)

Study arms

Placebo comparator
oxybutynin and clonidine oral solution treatment D
Placebo
Drug: oxybutynin and clonidine oral solution treatment D
Experimental
oxybutynin and clonidine oral solution treatment C
High dose oxybutynin and clonidine
Drug: oxybutynin and clonidine oral solution treatment C
Experimental
oxybutynin and clonidine oral solution treatment A
Low dose oxybutynin and clonidine
Drug: oxybutynin and clonidine oral solution treatment A
Experimental
oxybutynin and clonidine oral solution treatment B
Intermediate dose oxybutynin and clonidine
Drug: oxybutynin and clonidine oral solution treatment B

Interventions

Drugoxybutynin and clonidine oral solution treatment A
Also known as: OP-014
Drugoxybutynin and clonidine oral solution treatment B
Also known as: OP-014
Drugoxybutynin and clonidine oral solution treatment C
Also known as: OP-014
Drugoxybutynin and clonidine oral solution treatment D
Placebo
Also known as: Placebo

What researchers measure

Primary outcomes

Saliva Secreted Rate
Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
Time frame: 8 hours post-dose

Secondary outcomes

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.
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
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.
Time frame: during the study treatment period and follow up period at least 23 days excluding the screening period.

Results

Posted Apr 10, 2023

Limitations and caveats

Due to adverse event, one female patient (randomized number R24) did not complete her 4th study treatment (Treatment D/Placebo) in this 4-way cross over study.

Participant flow

This single center Phase II study was initated on 02 Aug 2011. First patient was screened on 25 Aug 2011. All the study patients were recruited from medical clinic and the patient recruitment ended on 23 Aug 2012.The last study patient completed study on 19 Sep 2012.

First Intervention

Participant flow — First Intervention
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	6	6	6
Completed	6	6	6	6
Not completed	0	0	0	0

Washout Period of >=5 Days

Participant flow — Washout Period of >=5 Days
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	6	6	6
Completed	6	6	6	6
Not completed	0	0	0	0

Second Intervention

Participant flow — Second Intervention
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	6	6	6
Completed	6	6	6	6
Not completed	0	0	0	0

Washout Period of >=5 Days

Participant flow — Washout Period of >=5 Days
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	6	6	6
Completed	6	6	6	6
Not completed	0	0	0	0

Third Intervention

Participant flow — Third Intervention
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	6	6	6
Completed	6	5	6	6
Not completed	0	1	0	0

Washout Period of >=5 Days

Participant flow — Washout Period of >=5 Days
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	5	6	6
Completed	6	5	6	6
Not completed	0	0	0	0

Fourth Intervention

Participant flow — Fourth Intervention
Milestone	Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C	Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D	Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A	Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Started	6	5	6	6
Completed	6	5	6	6
Not completed	0	0	0	0

Outcome measures

PrimarySaliva Secreted Rate

Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.

Time frame:: 8 hours post-dose
Reported as:: Mean · percentage of change from baseline

Saliva Secreted Rate
percentage of change from baseline	OC Oral Solution Treatment B	OC Oral Solution Treatment C	OC Oral Solution Treatment D	OC Oral Solution Treatment A
Saliva Secreted Rate	-6.508 ± 0.165	-34.512 ± 0.147	83.695 ± 0.281	7.414 ± 0.175

SecondaryNumeric 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.

Time frame:: 8 hours post-dose
Reported as:: Mean · score on a scale

Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production
score on a scale	OC Oral Solution Treatment A	OC Oral Solution Treatment B	OC Oral Solution Treatment C	OC Oral Solution Treatment D
Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production	-0.8 ± 1.74	-1.2 ± 1.71	-1.6 ± 1.74	-1.1 ± 1.83

SecondaryEvaluation 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.

Time frame:: during the study treatment period and follow up period at least 23 days excluding the screening period.
Reported as:: Number · Treatment Emergent Adverse Events

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
Treatment Emergent Adverse Events	OC Oral Solution Treatment A	OC Oral Solution Treatment B	OC Oral Solution Treatment C	OC Oral Solution Treatment D
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	6	6	5	4

Adverse events

Collected over 23 days for experimental period and follow up period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OC Oral Solution Treatment A	—	0/24 (0%)	6/24 (25%)
OC Oral Solution Treatment B	—	0/24 (0%)	6/24 (25%)
OC Oral Solution Treatment C	—	0/24 (0%)	5/24 (20.8%)
OC Oral Solution Treatment D	—	0/23 (0%)	4/23 (17.4%)

Most frequent other events

Most frequent other events
Event	OC Oral Solution Treatment A	OC Oral Solution Treatment B	OC Oral Solution Treatment C	OC Oral Solution Treatment D
SomnolenceNervous system disorders	0/24	0/24	1/24	2/23
Urinary tract infectionInfections and infestations	2/24	2/24	2/24	1/23
DizzinessNervous system disorders	2/24	0/24	2/24	0/23
DiarrhoeaGastrointestinal disorders	0/24	0/24	0/24	1/23
NauseaGastrointestinal disorders	0/24	1/24	0/24	0/23
Gait disturbanceGeneral disorders	0/24	1/24	0/24	0/23
Tooth infectionInfections and infestations	0/24	1/24	0/24	0/23
Heart rate irregularInvestigations	1/24	0/24	0/24	0/23
HallucinationPsychiatric disorders	0/24	1/24	0/24	0/23
ChokingRespiratory, thoracic and mediastinal disorders	1/24	0/24	0/24	0/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	2	4	3	4	13
>=65 years	4	2	3	2	11

Age, Continuous
Age, Continuous(years)	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Total
Mean	64 ± 6.46	64 ± 6.5	62 ± 7.45	62.8 ± 7.0	63 ± 7.62

Sex: Female, Male
Sex: Female, Male(Participants)	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Total
Female	2	2	2	1	7
Male	4	4	4	5	17

Region of Enrollment
Region of Enrollment(participants)	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Total
United States	6	6	6	6	24

Study locations

1 site

QUEST Research Institute
Bingham Farms, Michigan 48025, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01370811
Lead sponsor: Orient Pharma Co., Ltd.
Responsible party: Sponsor
First posted: Jun 10, 2011
Start date: Aug 2011
Primary completion: Sep 2012
Completion: Sep 2012
Results posted: Apr 10, 2023
Last update: Apr 10, 2023

Study contacts

Aaron L Ellenbogen, DO, MPH

principal investigator · QUEST Research Institute

Chi-Tai Chang, PhD

study director · Orient Pharma Co., Ltd.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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

Study summary

Conditions studied

Browse trials for

Keywords

In context

Sialorrhea

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria