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

21 de agosto de 2017 actualizado por: GlaxoSmithKline

A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.

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

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

343

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10178
        • GSK Investigational Site
      • Berlin, Alemania, 12163
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Alemania, 80331
        • GSK Investigational Site
      • Nuernberg, Bayern, Alemania, 90402
        • GSK Investigational Site
      • Unterhaching, Bayern, Alemania, 82008
        • GSK Investigational Site
    • Niedersachsen
      • Achim, Niedersachsen, Alemania, 28832
        • GSK Investigational Site
      • Hildesheim, Niedersachsen, Alemania, 31134
        • GSK Investigational Site
      • Westerstede, Niedersachsen, Alemania, 26655
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bielefeld, Nordrhein-Westfalen, Alemania, 33647
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Alemania, 01097
        • GSK Investigational Site
    • Thueringen
      • Gera, Thueringen, Alemania, 07551
        • GSK Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1527
        • GSK Investigational Site
      • Sofia, Bulgaria, 1113
        • GSK Investigational Site
      • Varna, Bulgaria, 9010
        • GSK Investigational Site
  • Canadá
      • Québec, Canadá, G1R 3X5
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3J 3T1
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Canadá, K1G 4G3
        • GSK Investigational Site
      • Toronto, Ontario, Canadá, M5T 2S8
        • GSK Investigational Site
      • Windsor, Ontario, Canadá, N8X 5A6
        • GSK Investigational Site
  • Chequia
      • Brno, Chequia, 625 00
        • GSK Investigational Site
      • Ostrava - Poruba, Chequia, 708 52
        • GSK Investigational Site
      • Pardubice, Chequia, 535 03
        • GSK Investigational Site
      • Praha 2, Chequia, 120 00
        • GSK Investigational Site
      • Praha 5, Chequia, 150 18
        • GSK Investigational Site
  • España
      • Alcorcon (Madrid), España, 28922
        • GSK Investigational Site
      • Barcelona, España, 08025
        • GSK Investigational Site
      • Madrid, España, 28007
        • GSK Investigational Site
      • San Sebastian, España, 20011
        • GSK Investigational Site
      • Sant Cugat del Valles (Barcelona), España, 08190
        • GSK Investigational Site
      • Sevilla, España, 41013
        • GSK Investigational Site
      • Sevilla, España, 41071
        • GSK Investigational Site
  • Federación Rusa
      • Moscow, Federación Rusa, 125101
        • GSK Investigational Site
      • Moscow, Federación Rusa, 117049
        • GSK Investigational Site
      • Moscow, Federación Rusa, 125367
        • GSK Investigational Site
      • Moscow, Federación Rusa, 119881
        • GSK Investigational Site
      • Moscow, Federación Rusa, 117593
        • GSK Investigational Site
      • St-Petersburg, Federación Rusa, 194354
        • GSK Investigational Site
      • St. Petersburg, Federación Rusa, 197022
        • GSK Investigational Site
      • St.-Petersburg, Federación Rusa, 194291
        • GSK Investigational Site
  • Francia
      • Aix en Provence, Francia, 13616
        • GSK Investigational Site
      • Clermont Ferrand, Francia, 63003
        • GSK Investigational Site
      • Dijon, Francia, 21000
        • GSK Investigational Site
      • Lille Cedex, Francia, 59037
        • GSK Investigational Site
      • Marseille, Francia, 13385
        • GSK Investigational Site
      • Paris Cedex 14, Francia, 75674
        • GSK Investigational Site
  • Hungría
      • Budapest, Hungría, 1021
        • GSK Investigational Site
      • Budapest, Hungría, 1135
        • GSK Investigational Site
      • Debrecen, Hungría, 4012
        • GSK Investigational Site
      • Szeged, Hungría, 6725
        • GSK Investigational Site
  • Italia
    • Abruzzo
      • Chieti Scalo, Abruzzo, Italia, 66013
        • GSK Investigational Site
    • Campania
      • Napoli, Campania, Italia, 80131
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italia, 00163
        • GSK Investigational Site
      • Roma, Lazio, Italia, 00148
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italia, 16132
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italia, 20142
        • GSK Investigational Site
      • Milano, Lombardia, Italia, 20133
        • GSK Investigational Site
      • Milano, Lombardia, Italia, 20126
        • GSK Investigational Site
    • Toscana
      • Grosseto, Toscana, Italia, 58100
        • GSK Investigational Site
      • Lido di Camaiore (Lucca), Toscana, Italia, 55043
        • GSK Investigational Site
    • Veneto
      • Arcugnano (VI), Veneto, Italia, 36057
        • GSK Investigational Site
  • Polonia
      • Gdansk, Polonia, 80-299
        • GSK Investigational Site
      • Katowice, Polonia, 40-752
        • GSK Investigational Site
      • Krakow, Polonia, 31-530
        • GSK Investigational Site
      • Lublin, Polonia, 20-718
        • GSK Investigational Site
      • Poznan, Polonia, 61-298
        • GSK Investigational Site
      • Warsaw, Polonia, 02-097
        • GSK Investigational Site
  • Reino Unido
      • Chertsey, Reino Unido, KT16 0QA
        • GSK Investigational Site
      • Leigh, Reino Unido, WN7 1HS
        • GSK Investigational Site
      • Oxford, Reino Unido, OX3 9DU
        • GSK Investigational Site
    • Gloucestershire
      • Bristol, Gloucestershire, Reino Unido, BS16 1LE
        • GSK Investigational Site
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, Reino Unido, ST4 7PA
        • GSK Investigational Site
  • Rumania
      • Bucharest, Rumania, 11241
        • GSK Investigational Site
      • Cluj Napoca, Rumania, 400012
        • GSK Investigational Site
  • Sudáfrica
      • Bloemfontein, Sudáfrica, 9301
        • GSK Investigational Site
      • Cape Town, Sudáfrica, 7925
        • GSK Investigational Site
      • Sunninghill, Sudáfrica, 2157
        • GSK Investigational Site
    • Gauteng
      • Pretoria, Gauteng, Sudáfrica, 0040
        • GSK Investigational Site
  • Ucrania
      • Kyiv, Ucrania, 01021
        • GSK Investigational Site
      • Kyiv, Ucrania, 04114
        • GSK Investigational Site
      • Poltava, Ucrania, 36024
        • GSK Investigational Site
      • Vinnitsa, Ucrania, 21005
        • GSK Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)
Periodo de tiempo: Baseline (Week 0) and Week 24
Diary cards completed by the participants was used to assess the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented.
Baseline (Week 0) and Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
Diary cards completed by the Participants was used to assess the duration of "off" and "on" periods. During the Treatment Period 2 24 hour diary cards were completed by the Participants (except for the Baseline Period when four diary cards were completed). The Participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.
Baseline (Week 0) and Week 24
Number of participants with a score of 'much improved' or 'very much improved' on the clinical global impression-global improvement (CGI-I) scale at Week 24 LOCF
Periodo de tiempo: Week 24
The CGI-I global improvement scale allows the investigator to rate the participant's total improvement from beginning the treatment (baseline). The scale was rated as 1-7, from 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse and 7: very much worse. CGI global improvement scale was assessed at Week 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24 (and at early withdrawal, if applicable. Higher score indicates worsening and lower score indicates very much improvement. A participant was considered as a CGI-I responder when he/she had a score of (1) Very Much Improved or (2) Much Improved.
Week 24
Mean change from baseline in the total motor score (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. "On" state was where PD symptoms were well controlled by the drug. Week 0 was the Baseline and change from Baseline for an individual participant was calculated by subtracting the Baseline values from the on-treatment values. Mean change from Baseline in the total motor score with participants in an "on" state was reported.
Baseline (Week 0) and Week 24
Mean change from baseline in the total motor score (part III) of the UPDRS, with participants in an "off" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The UPDRS Part III assessed motor examination on 18-31 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms and lower score indicates less severe PD symptoms. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values. Mean change from baseline in the total motor score with participants in an "off" state was reported.
Baseline (Week 0) and Week 24
Mean change from baseline in the total Activities of daily living (ADL) score (part II) of the UPDRS, with participants in an "on" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "On" state was where PD symptoms were well controlled by the drug. Week 0 was the Baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.
Baseline (Week 0) and Week 24
Mean change from baseline in the total ADL score (part II) of the UPDRS, with participants in an "off" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
This component included items 5-17 of the UPDRS was evaluated by calculating the total score for the 13 items. Participants receive a score of 0-4 points per item and had a value ranging from 0 to 52. The maximum total score was 52. The total ADL Score of the UPDRS ranged from 0 to 52, where 0=normal/no symptoms and 52=worst possible case. Participants recorded responses in both "on" and "off" states at each visit due to the nature of questionnaire which generated ADL score at each visit. A higher score indicates more severe PD symptoms. "Off" state was where PD symptoms were not adequately controlled by the drug. Week 0 was the baseline and change from Baseline for an individual participant was calculated by subtracting the baseline values from the on-treatment values for each state separately.
Baseline (Week 0) and Week 24
Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "on" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score )and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "on" state of Parkinson's. Baseline was defined as Week 0 assesment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline (Week 0) and Week 24
Mean change from baseline in the total score (parts I-III) of the UPDRS, with participants in an "off" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scored mentation, behavior and mood and scores ranged from 0-16. The UPDRS Part II was the ADL and score ranged from 0-52. The UPDRS Part III was the Motor Examination (Total Motor Score)and scores ranged from 0-108. The total UPDRS (Part I + II + III) score ranged from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant was in the "off" state of Parkinson's. Baseline was defined as Week 0 assessment. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Baseline (Week 0) and Week 24
Mean change from baseline to Week 24 LOCF in the thermometer score of the Euro-Qol 5D (EQ-5D)
Periodo de tiempo: Baseline (Week 0) and Week 24
The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Thermometer was a 20-cm Visual Analogue Scale (VAS) anchored at 0: worse imaginable health state and 100: best imaginable health state. Participants were required to indicate how good or bad was their health by marking a line on the scale. The point at which the line crossed the thermometer was taken as the score. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.
Baseline (Week 0) and Week 24
Mean change from baseline to Week 24 LOCF in the utility score of the EQ-5D
Periodo de tiempo: Baseline (Week 0) and Week 24
The EQ-5D was a standardized, participant-administered instrument which produced a simple descriptive profile (thermometer) and a single index value (utility) of a participant's current health status. Utility score was computed from 5 dimensions of health: (mobility, self-care, usual activities, pain/discomfort, anxiety /depression). Each dimension comprised 3 levels (some, moderate, extreme problems), and generated a total of 243 theoretically possible health states. The Utility score was combined scores from 5 dimensions, which valued between -0.594 (representing the worse possible health) and 1 (representing the perfect health). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.
Baseline (Week 0) and Week 24
Mean change from Baseline in the total score of the Parkinson's Disease Sleep Scale (PDSS) at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The PDSS comprised of a series of 15 VAS addressing commonly reported symptoms associated with sleep disturbance in PD. The participant or caregiver completed the scale based on their experiences in the past week. Scores for each item ranged from 0 (representing the most severe) to 10 (the least severe). The maximum score for the PDSS was 150 (participant was free of all symptoms). Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.
Baseline (Week 0) and Week 24
Mean change from Baseline in the total movement severity score of the abnormal involuntary movement scale (AIMS), with participants in an "on" state at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The AIMS was a 12 item, investigator performed assessment of facial and oral movements, extremity movements, trunk movements, global judgments and dental status according to predefined criteria. Items 1-10 were rated on a 5 point severity scale with 0: none to 4: severe. Items 11 and 12 were yes or no items. The AIMS total movement severity score was obtained by summing together the responses to the first seven items and ranged from 0 to 28, with higher scores representing more severe involuntary movement. The AIMS was assessed at Week 0, 12, 24. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.
Baseline (Week 0) and Week 24
Percentage of participants requiring re-instatement of L-dopa
Periodo de tiempo: Week 24
Participants were defined as having a re-instatement of L-dopa, if at any point during the on-treatment phase (excluding down-titration), their dose of L-dopa was increased, up to, or above their baseline level. Percentage of participants requiring reinstatement of L-dopa was reported at Week 24.
Week 24
Mean change from baseline in the dose of L-dopa at Week 24 LOCF
Periodo de tiempo: Baseline (Week 0) and Week 24
The start and stop dates of L-Dopa medication were used to determine the dose being taken on a specific date or at an assessment. The dose recorded on the actual date of assessment was used when reporting the corresponding dose. The total daily dose of L-dopa (mg) was calculated as Unit dose per tablet (mg) * Daily Frequency * No of Tablets per administration. Mean change from baseline in the dose of L-dopa at Week 24 was reported. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values from the on-treatment values.
Baseline (Week 0) and Week 24
Incidence of all adverse events (AE) and serious adverse events (SAE)
Periodo de tiempo: Up to Week 27
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Up to Week 27
Number of participants who were unable to titrate weekly during the 4 week forced up titration due to poor tolerability
Periodo de tiempo: Up to Week 24
There was no specific question in the CRF to capture the reason why participants were unable to titrate weekly during this period, the data on the reason for withdrawal in the CRF was thus evaluated in those participants who withdrew during the forced titration period. Data for the number of participants withdrawn (Yes/No) is presented.
Up to Week 24

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de junio de 2006

Finalización primaria (Actual)

29 de agosto de 2007

Finalización del estudio (Actual)

29 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2006

Primero enviado que cumplió con los criterios de control de calidad

26 de mayo de 2006

Publicado por primera vez (Estimar)

29 de mayo de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

21 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ROP105323

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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