Trial · NCT01370811
A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
NCT01370811, Phase 2, Completed, Orient Pharma Co., Ltd.; results first posted 2023-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease. Trials, record NCT01370811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01370811
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease
- NCT number
- NCT01370811
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Orient Pharma Co., Ltd.
- Conditions
- Sialorrhoea
- Interventions
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
- First posted
- 2011-06-10
- Last updated
- 2023-04-10
- Results first posted
- 2023-04-10
- 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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Saliva Secreted Rate | 8 hours post-dose | Change from baseline, negative mean reduce secret rate from baseline, positive mean not reduce secretion. |
| Secondary | Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | 8 hours post-dose | 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. |
| 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 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Saliva Secreted Rate | 8 hours post-dose | percentage of change from baseline | MEAN | |
| SECONDARY | Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | 8 hours post-dose | score on a scale | MEAN | |
| 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 | during the study treatment period and follow up period at least 23 days excluding the screening period. | Treatment Emergent Adverse Events | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Saliva Secreted Rate | OC Oral Solution Treatment B | -6.508 | Standard Deviation 0.165 | percentage of change from baseline | |
| Saliva Secreted Rate | OC Oral Solution Treatment C | -34.512 | Standard Deviation 0.147 | percentage of change from baseline | |
| Saliva Secreted Rate | OC Oral Solution Treatment D | 83.695 | Standard Deviation 0.281 | percentage of change from baseline | |
| Saliva Secreted Rate | OC Oral Solution Treatment A | 7.414 | Standard Deviation 0.175 | percentage of change from baseline | |
| Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | OC Oral Solution Treatment A | -0.8 | Standard Deviation 1.74 | score on a scale | |
| Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | OC Oral Solution Treatment B | -1.2 | Standard Deviation 1.71 | score on a scale | |
| Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | OC Oral Solution Treatment C | -1.6 | Standard Deviation 1.74 | score on a scale | |
| Numeric Rating Scale (NRS) Measurements of Subjective Judgment of Excessive Saliva Production | OC Oral Solution Treatment D | -1.1 | Standard Deviation 1.83 | score on a scale | |
| 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 | OC Oral Solution Treatment A | 6 | 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 | OC Oral Solution Treatment B | 6 | Treatment Emergent Adverse Events |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C | 6 | |
| First Intervention | STARTED | Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D | 6 | |
| First Intervention | STARTED | Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A | 6 | |
| First Intervention | STARTED | Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B | 6 | |
| First Intervention | COMPLETED | Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C | 6 | |
| First Intervention | COMPLETED | Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D | 6 | |
| First Intervention | COMPLETED | Sequence 3: Treatment C→Treatment D→Treatment B→Treatment A | 6 | |
| First Intervention | COMPLETED | Sequence 4: Treatment D→Treatment A→Treatment C→Treatment B | 6 | |
| First Intervention | NOT COMPLETED | Sequence 1: Treatment A→Treatment B→Treatment D→Treatment C | 0 | |
| First Intervention | NOT COMPLETED | Sequence 2: Treatment B→Treatment C→Treatment A→Treatment D | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | OC Oral Solution Treatment A | 0 | 24 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | OC Oral Solution Treatment B | 0 | 24 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | OC Oral Solution Treatment C | 0 | 24 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | OC Oral Solution Treatment D | 1 | 23 | 1 |
| other | Nausea | Gastrointestinal disorders | OC Oral Solution Treatment A | 0 | 24 | 0 |
| other | Nausea | Gastrointestinal disorders | OC Oral Solution Treatment B | 1 | 24 | 1 |
| other | Nausea | Gastrointestinal disorders | OC Oral Solution Treatment C | 0 | 24 | 0 |
| other | Nausea | Gastrointestinal disorders | OC Oral Solution Treatment D | 0 | 23 | 0 |
| other | Gait disturbance | General disorders | OC Oral Solution Treatment A | 0 | 24 | 0 |
| other | Gait disturbance | General disorders | OC Oral Solution Treatment B | 1 | 24 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OC Oral Solution Treatment A | ||
| Total, all-cause mortality | OC Oral Solution Treatment B | ||
| Total, all-cause mortality | OC Oral Solution Treatment C | ||
| Total, all-cause mortality | OC Oral Solution Treatment D | ||
| Total, other adverse events | OC Oral Solution Treatment A | 6 | 24 |
| Total, other adverse events | OC Oral Solution Treatment B | 6 | 24 |
| Total, other adverse events | OC Oral Solution Treatment C | 5 | 24 |
| Total, other adverse events | OC Oral Solution Treatment D | 4 | 23 |
| Total, serious adverse events | OC Oral Solution Treatment A | 0 | 24 |
| Total, serious adverse events | OC Oral Solution Treatment B | 0 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01370811
GET https://conductscience.org/api/trials/v1/NCT01370811/flow?page=2