Last updated: 11/03/2018 19:10:17

A Post-Marketing Surveillance Study of Requip PD™ (Ropinirole) in the Treatment of Adult Filipino Patients diagnosed with Parkinson’s DiseaseRequip PD PMS

GSK study ID
116456
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Discontinued
Discontinued
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Post-Marketing Surveillance Study of Requip PD™ (Ropinirole) in the Treatment of Adult Filipino Patients diagnosed with Parkinson’s Disease
Trial description: The study is Philippine FDA mandated study for Requip PD™ (Ropinirole) during the first three years of its marketing. The study will be run for three years to enrol 3000 patients who have been prescribed with Requip PD™ (Ropinirole). The main objective of the study is to assess the safety profile of Requip PD™ (Ropinirole) in the treatment of Filipino patients diagnosed with Parkinson’s Disease.
Study medication will be acquired via normal clinical practice. Safety Parameters will be assessed recording by recording adverse event experiences either noted by the doctor or spontaneously reported by the patient.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Adverse event report

Timeframe: 2 months post prescription

Secondary outcomes:
Not applicable
Interventions:
Drug: Requip PD™ (Ropinirole) 2mg
Enrollment:
18
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
January 2012 to July 2015
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18Years - 80Years
Accepts healthy volunteers
None
  • Adult patients (including elderly) with clinically diagnosed Parkinson’s disease
  • Patients must give written informed consent to take part in the study
  • Patients with known hypersensitivity to Ropinirole or any component of the preparation
Inclusion and exclusion criteria
Inclusion criteria:
  • Adult patients (including elderly) with clinically diagnosed Parkinson’s disease
  • Patients must give written informed consent to take part in the study
  • As per recommendation of Requip™ PD (Ropinirole) prescribing information.
Exclusion criteria:
  • Patients with known hypersensitivity to Ropinirole or any component of the preparation

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Discontinued
Actual primary completion date
Not applicable
Actual study completion date
2015-22-07

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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