- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00819065
Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity
6 lipca 2011 zaktualizowane przez: Hospital de Clinicas de Porto Alegre
Randomized Double-blind Clinical Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity
The purpose of this study is to compare the effectiveness between two commercial formulations of botulinum toxin type A in the treatment of spasticity through the Ashworth scale.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Botulinum toxin type A has been used clinically in spasticity treatment for over a decade.
There are, nowadays, three commercial formulations of BTA, wich, though the same type of toxin, are different biological products that differ about storage, dilution and dosage.
The units of one toxin are exclusive of that product, and an international standard-unit lacks.
Each kind of BTA has been through validation and safety studies, but there are very few comparative studies between them.
Thus, the purpose of this study is to compare the efficacy between two commercial formulations of BTA in the treatment of spasticity.
We will also evaluate the safety, adverse effects and cost of each formulation.
Will be included in this study patients currently in treatment with BTA/with indication for BTA treatment for spasticity, who must not have any contraindications for the drug, at the Spasticity outpatient clinic of the Hospital de Clínicas de Porto Alegre.
All patients included must agree to participate in the study by signing an informed consent form.Patients will be randomized into two groups of 28 individuals each (total of 56 patients) and will receive BTA from laboratory Allergan and Lanzhou, one at time of allocation and the other three months after, in a crossover model.
These drugs are both approved by ANVISA for the treatment of spasticity and provided by the national public health system (SUS).
Application will be performed by a trained investigator, unaware of the kind of BTA in use.
Standard dilutions of both toxins will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume, assuring appropriate masking.
Follow-up visits will be performed after four, twelve, sixteen and twenty-four weeks, by investigator unaware of the kind of BTA in use.
The modified Ashworth Scale will be applied at every visit by three medical investigators isolatedly, duly trained and blinded to the intervention.
Life quality will be assessed at time of allocation, four and twelve weeks after, using WHOQOL-Bref, YQOL-R and Children's Life Quality Assessment Questionnaire, respecting the age of the patient.
Functional capability will also be evaluated, through the Functional Independence Measure Scale (FIM) for adults and PEDI scale for children, at the same time frames as the life quality assessment instruments.
The primary end-point consists on the maximum degree of effect assessed through passive measurement of muscular tonus and quantified by the modified Ashworth Scale.
Secondary end-points are presence, kind and duration of adverse effects of each treatment and perception of improvement of symptoms by the patient himself or caregiver.
Statistical analysis will be performed using the SPSS package for Windows and descriptive analysis will be provided by absolute and relative frequencies and average±standard deviation for quantitative variables and percentages for qualitative ones.
The T of Student or Mann-Whitney tests will be used for independent samples, and chi-square and Fischer's exact tests will be performed when necessary.
Significance level will be 5%.There will be no additional risk for the patients, since the drugs involved in this trial have already been tested individually for efficacy and safety and are currently being used in medical practice for the treatment of these conditions.
The Public Health State Secretariat will be responsible for providing the drugs, according to routine pharmaceutical assistance, and there will be no additional cost for the hospital nor health system.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
56
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazylia
- Hospital de Clinicas de Porto Alegre
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
2 lata i starsze (Dziecko, Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- To be included, patients must have diagnosis of Spasticity by IC10 criteria.
- We will enroll patients on current treatment for spasticity at the Spasticity outpatient clinic of HCPA, already in treatment with BTA or starting that treatment based on their doctors' decision, who are willing to participate in the trial by signing an informed consent form.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: 1-BTA Lanzhou/Allergan
Patients randomly allocated to this arm will receive botulinum toxin type A from laboratory Lanzhou at allocation and after twelve weeks will receive the same drug from laboratory Allergan.
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Patients will receive botulinum toxin type A from laboratory Lanzhou either at time of allocation (arm BTA Lanzhou/Allergan) or three months later (arm BTA Allergan/Lanzhou), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of TBA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Inne nazwy:
Patients will receive botulinum toxin type A from laboratory Allergan either at time of allocation (arm BTA Allergan / Lanzhou) or three months later (arm BTA Lanzhou /Allergan), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of BTA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Inne nazwy:
|
Aktywny komparator: 2. BTA Allergan/Lanzhou
Patients randomly allocated to this arm will receive botulinum toxin type A from laboratory Allergan at allocation and after twelve weeks will receive the same drug from laboratory Lanzhou.
|
Patients will receive botulinum toxin type A from laboratory Lanzhou either at time of allocation (arm BTA Lanzhou/Allergan) or three months later (arm BTA Allergan/Lanzhou), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of TBA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Inne nazwy:
Patients will receive botulinum toxin type A from laboratory Allergan either at time of allocation (arm BTA Allergan / Lanzhou) or three months later (arm BTA Lanzhou /Allergan), so that all patients will receive both drugs in a crossover model.
Application will be performed according to standard protocol and respecting parameters of the patients former sessions (if there were any), by a trained investigator, unaware of the kind of BTA in use.
Standard dilution will be employed, within the usual dose and application spots (for patients already in treatment) or standard (for patients yet to start treatment).
Identical dose will be used, with 2ml of saline solution 0,9% dilution for each 100units, thus, there will be no difference for the patient or investigator concerning the applicated volume.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Muscle tonus reduction will be assessed by the Ashworth Scale.
Ramy czasowe: time of allocation, four, twelve, sixteen and twenty-four weeks after first application of toxin.
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time of allocation, four, twelve, sixteen and twenty-four weeks after first application of toxin.
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
---|---|
Life quality will be assessed by WHOQOL-Bref, YQOL-R and Children's Life Quality assessment questionnaire, respecting the age of the patient.
Ramy czasowe: time of allocation, twelve and twenty-four weeks after first application of toxin.
|
time of allocation, twelve and twenty-four weeks after first application of toxin.
|
Functional capability will be evaluated through the Functional Independence Measure Scale (FIM) for adults and PEDI scale for children.
Ramy czasowe: time of allocation, twelve and twenty-four weeks after first application of toxin.
|
time of allocation, twelve and twenty-four weeks after first application of toxin.
|
Incidence, severity and duration of adverse effects of each treatment, through adverse events scale.
Ramy czasowe: every follow-up visit.
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every follow-up visit.
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Perception of improvement of the symptoms by the patient himself or caregiver.
Ramy czasowe: every follow-up visit.
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every follow-up visit.
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Paulo D Picon, Hospital de Clinicas de Porto Alegre
- Krzesło do nauki: Fábio C Guarany, Hospital de Clinicas de Porto Alegre
- Dyrektor Studium: Nicole Ruas, Hospital de Clinicas de Porto Alegre
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 marca 2009
Zakończenie podstawowe (Rzeczywisty)
1 maja 2010
Ukończenie studiów (Rzeczywisty)
1 czerwca 2011
Daty rejestracji na studia
Pierwszy przesłany
7 stycznia 2009
Pierwszy przesłany, który spełnia kryteria kontroli jakości
7 stycznia 2009
Pierwszy wysłany (Oszacować)
8 stycznia 2009
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
7 lipca 2011
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
6 lipca 2011
Ostatnia weryfikacja
1 lipca 2011
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Układu Nerwowego
- Objawy neurologiczne
- Choroby układu mięśniowo-szkieletowego
- Choroby mięśni
- Manifestacje nerwowo-mięśniowe
- Hipertonia mięśniowa
- Spastyczność mięśni
- Fizjologiczne skutki leków
- Agentów neuroprzekaźników
- Molekularne mechanizmy działania farmakologicznego
- Agenty obwodowego układu nerwowego
- Środki cholinergiczne
- Modulatory transportu membranowego
- Inhibitory uwalniania acetylocholiny
- Środki nerwowo-mięśniowe
- Toksyny botulinowe
- Toksyna botulinowa typu A
- abotoksyna botulinowa A
Inne numery identyfikacyjne badania
- 06336
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Botulinum toxin type A from laboratory Lanzhou
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Seoul National University HospitalDaewoong Pharmaceutical Co. LTD.NieznanySpastyczność jako następstwo udaruRepublika Korei