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
Other
Other
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
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    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
    Other
    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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    Access to clinical trial data by researchers
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