Trial · NCT00986245
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
NCT00986245, Phase 4, Completed, Seoul National University Hospital; results first posted 2013-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily. Trials, record NCT00986245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00986245
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
- NCT number
- NCT00986245
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 82 participants, actual
- Lead sponsor
- Seoul National University Hospital
- Conditions
- Parkinson Disease
- Interventions
- Ropinirole Prolonged release
- First posted
- 2009-09-29
- Last updated
- 2013-09-09
- Results first posted
- 2013-09-09
- Limitations and caveats
- This study was designed to open-label study. We cannot exclude the psychological effect of each regimen.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Preference | After 16 weeks or at last visit for early completion | Patient preference between once-daily and twice-daily regimen |
| Secondary | Unified Parkinson's Disease Rating Scale, Part 3 | 8 weeks for each arm or at last visit | Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion. UPDRS part 3 is motor scale for parkinson's disease. Range: 0\~108 Higher values represent more severe motor symptoms of parkinsonism. |
| Secondary | Hoehn and Yahr Stage | 8 weeks for each arm or at last visit | Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0\~5 Higher values represent more severe parkinsonism |
| Secondary | Overall Quality of Sleep | 8 weeks for each arm or at last visit | Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0\~10 Higher values represent worse overall sleep quality. |
| Secondary | Nocturnal Off-symptoms | 8 weeks for each arm or at last visit | Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0\~10 Higher values represent worse nocturnal off-symptoms. |
| Secondary | Early Morning Off Symptoms | 8 weeks for each arm or at last visit | Sleep questionnaire 3 for "early morning off symptoms" Visual analogue scale: 0\~10 Higher values represent worse early morning off symptoms. |
| Secondary | Epworth Sleep Scale | 8 weeks in each arm or at last visit for early completion | Epworth sleep scale after 8 weeks in each arm or at last visit for early completion. Range: 0\~24 Higher values represent worse daytime-sleepiness. |
| Secondary | Compliance | 8 weeks for each arm or at last visit | Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication. |
| Secondary | Adverse Events | After 8 weeks in each arm or at last visit for early completion | Patients who have adverse events |
| Secondary | Patients Who Have Global Impression for Improvement | After 8 weeks in each arm or at last visit for early completion | Patients who have global impression for improvement for each dosing. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Preference | After 16 weeks or at last visit for early completion | Primary outcome measure was the preference of the subjects between once-daily versus twice-daily of RPR at the completion or at early completion after crossover.~61 of participants completing period with study intervention. | participants | NUMBER |
| SECONDARY | Unified Parkinson's Disease Rating Scale, Part 3 | 8 weeks for each arm or at last visit | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or Twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | units on a scale | MEAN |
| SECONDARY | Hoehn and Yahr Stage | 8 weeks for each arm or at last visit | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. Once-daily or twice-daily arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | Scores on a scale | MEAN |
| SECONDARY | Overall Quality of Sleep | 8 weeks for each arm or at last visit | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | units on a scale | MEAN |
| SECONDARY | Nocturnal Off-symptoms | 8 weeks for each arm or at last visit | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | units on a scale | MEAN |
| SECONDARY | Early Morning Off Symptoms | 8 weeks for each arm or at last visit | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | units on a scale | MEAN |
| SECONDARY | Epworth Sleep Scale | 8 weeks in each arm or at last visit for early completion | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | units on a scale | MEAN |
| SECONDARY | Compliance | 8 weeks for each arm or at last visit | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | percentage of used medication | MEAN |
| SECONDARY | Adverse Events | After 8 weeks in each arm or at last visit for early completion | Total number of patients are 61 (Group 1 + Group 2), because of Crossover design. QD or BID arm means clinical variables measured in once-daily or twice-daily regimen, respectively. | participants | NUMBER |
| SECONDARY | Patients Who Have Global Impression for Improvement | After 8 weeks in each arm or at last visit for early completion | The number of patient who completed the study and answered the questionnaire for global impression. | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Preference | Once-daily | 17 | participants | ||
| Patient Preference | Twice-daily | 31 | participants | ||
| Patient Preference | No Preference | 13 | participants | ||
| Unified Parkinson's Disease Rating Scale, Part 3 | Once-daily of Ropinirole PR | 17.5 | Standard Deviation 8.2 | units on a scale | |
| Unified Parkinson's Disease Rating Scale, Part 3 | Twice-daily of Ropinirole PR | 17.1 | Standard Deviation 8.9 | units on a scale | |
| Hoehn and Yahr Stage | Once-daily of Ropinirole PR | 2.1 | Standard Deviation 0.5 | Scores on a scale | |
| Hoehn and Yahr Stage | Twice-daily of Ropinirole PR | 2.1 | Standard Deviation 0.6 | Scores on a scale | |
| Overall Quality of Sleep | Once-daily of Ropinirole PR | 2.9 | Standard Deviation 2.6 | units on a scale | |
| Overall Quality of Sleep | Twice-daily of Ropinirole PR | 3.2 | Standard Deviation 2.5 | units on a scale | |
| Nocturnal Off-symptoms | Once-daily of Ropinirole PR | 2.9 | Standard Deviation 3.2 | units on a scale |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Ropinirole PR-Once Daily First, Then Twice Daily | 41 | |
| First Intervention | STARTED | Ropinirole PR-Twice Daily First, Then Once Daily | 41 | |
| First Intervention | COMPLETED | Ropinirole PR-Once Daily First, Then Twice Daily | 31 | |
| First Intervention | COMPLETED | Ropinirole PR-Twice Daily First, Then Once Daily | 33 | |
| First Intervention | NOT COMPLETED | Ropinirole PR-Once Daily First, Then Twice Daily | 10 | |
| First Intervention | NOT COMPLETED | Ropinirole PR-Twice Daily First, Then Once Daily | 8 | |
| Second Intervention | STARTED | Ropinirole PR-Once Daily First, Then Twice Daily | 31 | |
| Second Intervention | STARTED | Ropinirole PR-Twice Daily First, Then Once Daily | 33 | |
| Second Intervention | COMPLETED | Ropinirole PR-Once Daily First, Then Twice Daily | 29 | |
| Second Intervention | COMPLETED | Ropinirole PR-Twice Daily First, Then Once Daily | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
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 | Nausea | Gastrointestinal disorders | Once-daily of Ropinirole PR | 9 | 61 | 9 |
| other | Nausea | Gastrointestinal disorders | Twice-daily of Ropinirole PR | 7 | 61 | 7 |
| other | Dizziness | General disorders | Once-daily of Ropinirole PR | 3 | 61 | 3 |
| other | Dizziness | General disorders | Twice-daily of Ropinirole PR | 4 | 61 | 4 |
| other | Somnolence | Nervous system disorders | Once-daily of Ropinirole PR | 1 | 61 | 1 |
| other | Somnolence | Nervous system disorders | Twice-daily of Ropinirole PR | 2 | 61 | 2 |
| other | Headache | Nervous system disorders | Once-daily of Ropinirole PR | 3 | 61 | 3 |
| other | Headache | Nervous system disorders | Twice-daily of Ropinirole PR | 1 | 61 | 1 |
| other | Constipation | Gastrointestinal disorders | Once-daily of Ropinirole PR | 20 | 61 | 20 |
| other | Constipation | Gastrointestinal disorders | Twice-daily of Ropinirole PR | 19 | 61 | 19 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Once-daily of Ropinirole PR | ||
| Total, all-cause mortality | Twice-daily of Ropinirole PR | ||
| Total, other adverse events | Once-daily of Ropinirole PR | 33 | 61 |
| Total, other adverse events | Twice-daily of Ropinirole PR | 28 | 61 |
| Total, serious adverse events | Once-daily of Ropinirole PR | 0 | 61 |
| Total, serious adverse events | Twice-daily of Ropinirole PR | 0 | 61 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation | Trial comparisons |
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: Patients Who Have Global Impression for Improvement to Severity of Dyskinesia | Trial comparisons |
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: Patients Who Have Global Impression for Improvement | Trial comparisons |
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: Adverse Events | Trial comparisons |
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: Patients Who Have Global Impression for Improvement to Duration of Dyskinesia | Trial comparisons |
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation | Trial comparisons |
| Once-daily of Ropinirole PR vs Twice-daily of Ropinirole PR: serious adverse events | Trial comparisons |
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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