Last updated: 03/05/2025 08:40:17
Special Drug Use Investigation for ReQuip® Controlled-Release (CR)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Special Drug Use Investigation for ReQuip® Controlled-Release (CR)
Trial description: This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data for long-term use among subjects with parkinson's disease who are treated with ropinirole tablets for the first time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse events of sudden onset of sleep
Timeframe: 1 year
Occurrence of adverse events of somnolence
Timeframe: 1 year
Changes in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) scores
Timeframe: 1 year
Occurrence of adverse drug reactions under clinical practice
Timeframe: 1 year
Occurrence of adverse events of psychiatric symptom such as hallucination, delusion, agitation, confusional state and delirium
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
667
Primary completion date:
2015-21-10
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Kazuko Hasegawa, Atsuko Ishida, Masao Yarita, Terufumi Hara. Assessment of Safety and Effectiveness of Ropinirole Hydrochloride Controlled-Release Tablets in Parkinson's Disease Patients in Long-Term Dairy Clinical Practice. -Report of Special Drug Use Investigation. Prog Med. 2016;36(6):97-100
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
October 2012 to October 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients with Parkinson's disease
- Patients who are treated with ropinirole tablets for the first time
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with Parkinson's disease
- Patients who are treated with ropinirole tablets for the first time
- Patients who are expected for long-term use (1 year)
Exclusion criteria:
- None
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2015-21-10
Actual study completion date
2015-21-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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