Trial Outcomes & Findings for A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease (NCT NCT01370811)
NCT ID: NCT01370811
Last Updated: 2023-04-10
Results Overview
Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
8 hours post-dose
Results posted on
2023-04-10
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.
After informed consent process, investigators screened 35 patients and successfully randomized 24 patients to receive study treatments. The other 11 patients were screening failure since they failed to meet study required inclusion and/or exclusion criteria.
Participant milestones
| Measure |
Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C
Treatment A:Oxybutynin 2.0 mg and clonidine 37.5 μg Treatment B: Oxybutynin 5.0 mg and clonidine 50.0 μg Treatment C: Oxybutynin 7.5 mg and clonidine 75.0 μg Treatment D:Placebo
|
Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D
Treatment B: Oxybutynin 5.0 mg and clonidine 50.0 μg Treatment C: Oxybutynin 7.5 mg and clonidine 75.0 μg Treatment A:Oxybutynin 2.0 mg and clonidine 37.5 μg Treatment D:Placebo
|
Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A
Treatment C: Oxybutynin 7.5 mg and clonidine 75.0 μg Treatment D:Placebo Treatment B: Oxybutynin 5.0 mg and clonidine 50.0 μg Treatment A:Oxybutynin 2.0 mg and clonidine 37.5 μg
|
Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B
Treatment D:Placebo Treatment A:Oxybutynin 2.0 mg and clonidine 37.5 μg Treatment C: Oxybutynin 7.5 mg and clonidine 75.0 μg Treatment B: Oxybutynin 5.0 mg and clonidine 50.0 μg
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
6
|
6
|
6
|
6
|
|
First Intervention
COMPLETED
|
6
|
6
|
6
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period of >=5 Days
STARTED
|
6
|
5
|
6
|
6
|
|
Washout Period of >=5 Days
COMPLETED
|
6
|
5
|
6
|
6
|
|
Washout Period of >=5 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
6
|
6
|
6
|
6
|
|
Second Intervention
COMPLETED
|
6
|
6
|
6
|
6
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
6
|
6
|
6
|
6
|
|
Third Intervention
COMPLETED
|
6
|
5
|
6
|
6
|
|
Third Intervention
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Fourth Intervention
STARTED
|
6
|
5
|
6
|
6
|
|
Fourth Intervention
COMPLETED
|
6
|
5
|
6
|
6
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Sequence 1
n=6 Participants
Treatment A→Treatment B→Treatment D→Treatment C
|
Sequence 2
n=6 Participants
Treatment B→Treatment C→Treatment A→Treatment D
|
Sequence 3
n=6 Participants
Treatment C→Treatment D→Treatment B→Treatment A
|
Sequence 4
n=6 Participants
Treatment D→Treatment A→Treatment C→Treatment B
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 6.46 • n=5 Participants
|
64 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
62 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
63 years
STANDARD_DEVIATION 7.62 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 hours post-doseChange from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion.
Outcome measures
| Measure |
OC Oral Solution Treatment B
n=24 Participants
Intermediate dose oxybutynin and clonidine
OC oral solution treatment B :
|
OC Oral Solution Treatment C
n=24 Participants
High dose oxybutynin and clonidine
OC oral solution treatment C :
|
OC Oral Solution Treatment D
n=23 Participants
Placebo
OC oral solution treatment D : Placebo
|
OC Oral Solution Treatment A
n=24 Participants
Low dose Oxybutynin and clonidine.
|
|---|---|---|---|---|
|
Saliva Secreted Rate
|
-6.508 percentage of change from baseline
Standard Deviation 0.165
|
-34.512 percentage of change from baseline
Standard Deviation 0.147
|
83.695 percentage of change from baseline
Standard Deviation 0.281
|
7.414 percentage of change from baseline
Standard Deviation 0.175
|
SECONDARY outcome
Timeframe: 8 hours post-doseEvaluation 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.
Outcome measures
| Measure |
OC Oral Solution Treatment B
n=24 Participants
Intermediate dose oxybutynin and clonidine
OC oral solution treatment B :
|
OC Oral Solution Treatment C
n=24 Participants
High dose oxybutynin and clonidine
OC oral solution treatment C :
|
OC Oral Solution Treatment D
n=24 Participants
Placebo
OC oral solution treatment D : Placebo
|
OC Oral Solution Treatment A
n=23 Participants
Low dose Oxybutynin and clonidine.
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production
|
-0.8 score on a scale
Standard Deviation 1.74
|
-1.2 score on a scale
Standard Deviation 1.71
|
-1.6 score on a scale
Standard Deviation 1.74
|
-1.1 score on a scale
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: during the study treatment period and follow up period at least 23 days excluding the screening period.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.
Outcome measures
| Measure |
OC Oral Solution Treatment B
n=24 Participants
Intermediate dose oxybutynin and clonidine
OC oral solution treatment B :
|
OC Oral Solution Treatment C
n=24 Participants
High dose oxybutynin and clonidine
OC oral solution treatment C :
|
OC Oral Solution Treatment D
n=24 Participants
Placebo
OC oral solution treatment D : Placebo
|
OC Oral Solution Treatment A
n=23 Participants
Low dose Oxybutynin and clonidine.
|
|---|---|---|---|---|
|
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 Treatment Emergent Adverse Events
|
6 Treatment Emergent Adverse Events
|
5 Treatment Emergent Adverse Events
|
4 Treatment Emergent Adverse Events
|
Adverse Events
OC Oral Solution Treatment A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OC Oral Solution Treatment B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
OC Oral Solution Treatment C
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OC Oral Solution Treatment D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OC Oral Solution Treatment A
n=24 participants at risk
Low dose oxybutynin and clonidine
OC oral solution treatment A :
|
OC Oral Solution Treatment B
n=24 participants at risk
Intermediate dose oxybutynin and clonidine
OC oral solution treatment B :
|
OC Oral Solution Treatment C
n=24 participants at risk
High dose oxybutynin and clonidine
OC oral solution treatment C :
|
OC Oral Solution Treatment D
n=23 participants at risk
Placebo
OC oral solution treatment D : Placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
4.3%
1/23 • Number of events 1 • 23 days for experimental period and follow up period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
|
General disorders
Gait disturbance
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • Number of events 2 • 23 days for experimental period and follow up period.
|
8.3%
2/24 • Number of events 2 • 23 days for experimental period and follow up period.
|
8.3%
2/24 • Number of events 2 • 23 days for experimental period and follow up period.
|
4.3%
1/23 • Number of events 1 • 23 days for experimental period and follow up period.
|
|
Investigations
Heart rate irregular
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
8.3%
2/24 • Number of events 2 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
8.7%
2/23 • Number of events 2 • 23 days for experimental period and follow up period.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
4.2%
1/24 • Number of events 1 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/24 • 23 days for experimental period and follow up period.
|
0.00%
0/23 • 23 days for experimental period and follow up period.
|
Additional Information
Aaron L. Ellenbogen, OD, MPH
Quest Research Institute
Phone: +1 248 644 7770
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60