MedDataX Logo

A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

NCT ID: NCT00331149

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-20

Study Completion Date

2007-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to compare the effectiveness and tolerability of a new prolonged release formulation of ropinirole with the currently marketed immediate release formulation which is prescribed in many countries. The new prolonged release formulation allows the drug to be taken once a day rather than three times a day. This study will also evaluate the side effects of the new prolonged release formulation of ropinirole

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

NCT01929317

Parkinson Disease
TERMINATED PHASE3

Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

NCT00823836

Parkinson Disease
COMPLETED PHASE3

Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa

NCT00381472

Parkinson Disease
COMPLETED PHASE3

REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

NCT00485069

Parkinson Disease Parkinson's Disease
COMPLETED PHASE4

A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease

NCT01494532

Parkinson Disease
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropinirole prolonged release

Intervention Type DRUG

ropinirole immediate release

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ropinirole prolonged release

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa.

Exclusion Criteria

* Patients with late stage advanced Parkinson's disease with incapacitating dyskinesias on a stable dose of L-dopa.
* Current, or history of, (within the previous 3 months), significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or active malignancy.
* Recent history of severe dizziness or fainting on standing.
* Dementia, neurotic behaviour, crippling degenerative arthritis or limb amputations, or prior or current major psychosis.
* Recent history or current evidence of drug abuse or alcoholism.
* Use of a dopamine agonist within 4 weeks of starting the study.
* Personal or family history of an allergic reaction to ropinirole.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Varna, , Bulgaria

Site Status

GSK Investigational Site

Halifax, Nova Scotia, Canada

Site Status

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Windsor, Ontario, Canada

Site Status

GSK Investigational Site

Québec, , Canada

Site Status

GSK Investigational Site

Brno, , Czechia

Site Status

GSK Investigational Site

Ostrava - Poruba, , Czechia

Site Status

GSK Investigational Site

Pardubice, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Aix-en-Provence, , France

Site Status

GSK Investigational Site

Clermont-Ferrand, , France

Site Status

GSK Investigational Site

Dijon, , France

Site Status

GSK Investigational Site

Lille, , France

Site Status

GSK Investigational Site

Marseille, , France

Site Status

GSK Investigational Site

Paris, , France

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Nuremberg, Bavaria, Germany

Site Status

GSK Investigational Site

Unterhaching, Bavaria, Germany

Site Status

GSK Investigational Site

Achim, Lower Saxony, Germany

Site Status

GSK Investigational Site

Hildesheim, Lower Saxony, Germany

Site Status

GSK Investigational Site

Westerstede, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Gera, Thuringia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Budapest, , Hungary

Site Status

GSK Investigational Site

Budapest, , Hungary

Site Status

GSK Investigational Site

Debrecen, , Hungary

Site Status

GSK Investigational Site

Szeged, , Hungary

Site Status

GSK Investigational Site

Chieti Scalo, Abruzzo, Italy

Site Status

GSK Investigational Site

Napoli, Campania, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Genoa, Liguria, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Milan, Lombardy, Italy

Site Status

GSK Investigational Site

Grosseto, Tuscany, Italy

Site Status

GSK Investigational Site

Lido Di Camaiore (Lucca), Tuscany, Italy

Site Status

GSK Investigational Site

Arcugnano (VI), Veneto, Italy

Site Status

GSK Investigational Site

Gdansk, , Poland

Site Status

GSK Investigational Site

Katowice, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Lublin, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Warsaw, , Poland

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Cluj-Napoca, , Romania

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Pretoria, Gauteng, South Africa

Site Status

GSK Investigational Site

Bloemfontein, , South Africa

Site Status

GSK Investigational Site

Cape Town, , South Africa

Site Status

GSK Investigational Site

Sunninghill, , South Africa

Site Status

GSK Investigational Site

Alcorcon (Madrid), , Spain

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Donostia / San Sebastian, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Sant Cugat Del Valles (Barcelona), , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Seville, , Spain

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

GSK Investigational Site

Poltava, , Ukraine

Site Status

GSK Investigational Site

Vinnitsa, , Ukraine

Site Status

GSK Investigational Site

Bristol, Gloucestershire, United Kingdom

Site Status

GSK Investigational Site

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status

GSK Investigational Site

Chertsey, , United Kingdom

Site Status

GSK Investigational Site

Leigh, , United Kingdom

Site Status

GSK Investigational Site

Oxford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria Canada Czechia France Germany Hungary Italy Poland Romania Russia South Africa Spain Ukraine United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ROP105323

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164
NCT00650104 COMPLETED PHASE3
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa
NCT01154166 COMPLETED PHASE3
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
NCT01485172 COMPLETED PHASE4
Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole
NCT00460148 COMPLETED PHASE2
Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
NCT00363727 COMPLETED PHASE3
Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)
NCT00434304 COMPLETED PHASE2
An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
NCT00632736 COMPLETED PHASE3
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
NCT00986245 COMPLETED PHASE4
Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
NCT01435915 COMPLETED PHASE1
A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda
NCT01371682 COMPLETED PHASE1
Efficacy of Isradipine in Early Parkinson Disease
NCT02168842 COMPLETED PHASE3
Stalevo in Early Wearing-Off Patients
NCT00125567 COMPLETED PHASE4
Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole
NCT03250117 TERMINATED PHASE1/PHASE2
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
NCT00986414 COMPLETED PHASE2
Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease
NCT00260793 UNKNOWN PHASE3
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
NCT05924243 COMPLETED PHASE1
A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's Disease
NCT00243971 COMPLETED PHASE3
Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
NCT01536574 COMPLETED PHASE3
Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
NCT00577460 COMPLETED PHASE3
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
NCT00391898 COMPLETED PHASE4
Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing Off
NCT00642356 TERMINATED PHASE4
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
NCT03257046 COMPLETED PHASE1/PHASE2
Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease
NCT02103465 TERMINATED PHASE2
A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.
NCT01829867 TERMINATED PHASE1
A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
NCT04658186 COMPLETED PHASE2