- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01256450
Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain
A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
Przegląd badań
Szczegółowy opis
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. During the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine HCl buccal film versus placebo buccal film in treating CLBP in subjects.
Buprenorphine HCl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a Schedule III controlled substance in the United States.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35209
- Alabama Orthopaedic Center - Research
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Mobile, Alabama, Stany Zjednoczone, 36608
- Coastal Clinical Research, Inc.
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85023
- Arizona Research Center
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California
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Fresno, California, Stany Zjednoczone, 93710
- Neuro-Pain Medical Center
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La Jolla, California, Stany Zjednoczone, 92037
- University of California, San Diego Medical Center, UCSD Center for Pain Medicine
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Long Beach, California, Stany Zjednoczone, 90806
- Collaborative Neuroscience Network, Inc.
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Florida
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DeLand, Florida, Stany Zjednoczone, 32720
- Avail Clinical Research, LLC
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Jupiter, Florida, Stany Zjednoczone, 33458
- Health Awareness, Inc.
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Plantation, Florida, Stany Zjednoczone, 33317
- Gold Coast Research, LLC
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Port Orange, Florida, Stany Zjednoczone, 32129
- Accord Clinical Research, LLC
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Georgia
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Marietta, Georgia, Stany Zjednoczone, 30060
- Taylor Research, LLC
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Illinois
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Bloomington, Illinois, Stany Zjednoczone, 61701
- Millennium Pain Center
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Indiana
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Evansville, Indiana, Stany Zjednoczone, 47714
- MediSphere Medical Research Center, LLC
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Kansas
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Leawood, Kansas, Stany Zjednoczone, 66211
- International Clinical Research Institute
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Massachusetts
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Watertown, Massachusetts, Stany Zjednoczone, 02472
- MedVadis Research Corporation
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89144
- Office of Stephen H. Miller, MD
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New York
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New York, New York, Stany Zjednoczone, 10022
- Research Across American
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North Carolina
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Raleigh, North Carolina, Stany Zjednoczone, 27612
- Wake Research Associates, LLC
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Winston-Salem, North Carolina, Stany Zjednoczone, 27103
- The Center for Clinical Research, LLC
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Pennsylvania
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Altoona, Pennsylvania, Stany Zjednoczone, 16602
- Allegheny Pain Management
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Texas
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Austin, Texas, Stany Zjednoczone, 78731
- FutureSearch Trials of Neurology
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El Paso, Texas, Stany Zjednoczone, 79902
- Southwest Urgent Care Center
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84106
- Lifetree Clinical Research
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West Jordan, Utah, Stany Zjednoczone, 84088
- Advanced Clinical Research
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Male or non-pregnant and non-nursing female aged 18 or older
- History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
- Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
- Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
- Female subjects of childbearing potential must be using a recognized effective method of birth control
- Written informed consent obtained at Screening, prior to any procedure being performed
Exclusion Criteria:
- Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
- Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
- Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
- History of long QT syndrome, or an immediate family member with this condition
- Diagnosis of moderate to severe hepatic impairment.
- History of severe emesis with opioids
- Clinically significant sleep apnea
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: BEMA Buprenorfina
buprenorfina rozpuszczalna błona policzkowa
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buccal soluble film; applied to the buccal mucosa twice daily
Inne nazwy:
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Komparator placebo: BEMA Placebo
placebo buccal soluble film
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buccal soluble film; applied to the buccal mucosa twice daily
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Pain Intensity From Baseline to Week 12
Ramy czasowe: Baseline, Week 12
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Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization.
Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
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Baseline, Week 12
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Zmiana od punktu początkowego do tygodnia 12 w kwestionariuszu niepełnosprawności Rolanda Morrisa
Ramy czasowe: Linia bazowa, tydzień 12
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Badani oceniają niepełnosprawność z powodu bólu pleców za pomocą Kwestionariusza Niepełnosprawności Rolanda Morrisa (RMDQ) składającego się z 24 stwierdzeń o niepełnosprawności.
Wynik RMDQ to całkowita liczba sprawdzonych pozycji, w zakresie od 0 do 24, przy czym wyższe wyniki wskazują na większą niepełnosprawność.
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Linia bazowa, tydzień 12
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Change From Baseline in Pain Intensity Over Time Using NRS Scale
Ramy czasowe: Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
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Change in pain intensity = average of daily pain scores from the last 7 days prior to each visit - average of daily pain scores for the last 7 days prior to randomization.
Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
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Baseline; Day 14, Day 28, Day 42, Day 56, Day 70, and Day 84
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Number of Participants With Response to Treatment as Assessed by an NRS Scale
Ramy czasowe: Week 12
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Responses are defined as the relative improvement in pain score at week 12 from baseline, calculated from ratings of average pain intensity over the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
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Week 12
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Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)
Ramy czasowe: Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
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Treatment failure is defined as study discontinuation due to lack of efficacy or due to adverse event in the double-blind treatment phase.
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Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)
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Subject Impression of Change in Pain Intensity From Baseline to Week 12 Using PGIC Scale
Ramy czasowe: Baseline, Week 12
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Subjects assessed changes in activity, limitations, symptoms, and overall quality of life related to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC), a balanced 7-point scale from 1 (no change or condition got worse) to 7 (a great deal better and considerable improvement that has made all the difference).
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Baseline, Week 12
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Change From Baseline to Week 12 in Treatment Satisfaction Using TSQM
Ramy czasowe: Baseline, Week 12
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The Treatment Satisfaction Questionnaire for Medication (TSQM) is a 14-item instrument used to assess the subject's satisfaction with the ability of the study medication to prevent or treat the condition of chronic low back pain (CLBP) for effectiveness, side effects, convenience, and global satisfaction.
Scores range from 0 to 100, where a higher score indicates less dissatisfaction (ie, greater satisfaction).
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Baseline, Week 12
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Change From Baseline to Week 12 in Subject's Overall Satisfaction With Study Drug
Ramy czasowe: Baseline, Week 12
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Subjects were asked to rate their overall satisfaction with their study drug on a 5-point scale ranging from 1 (poor) to 5 (excellent).
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Baseline, Week 12
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Change From Baseline to Week 12 in Investigator's Overall Satisfaction With Study Drug
Ramy czasowe: Baseline, Week 12
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Investigators rated their overall satisfaction with the study drug administered to a given subject on a 5-point scale ranging from 1 (poor) to 5 (excellent).
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Baseline, Week 12
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Use of Rescue Medication
Ramy czasowe: Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
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Calculated from the use of rescue medication recorded in subject diary as the sum of all rescue medication tablets used in the last 7 days previous to the derived visit, divided by the number of days in this duration where the amount was reported.
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Day 7, 14, 28, 42, 56, 70, 84, and 91 within double-blind treatment phase
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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Andrew Finn, PharmD, BioDelivery Sciences International, Inc.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- BUP-301
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 Buprenorphine
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BioDelivery Sciences InternationalZakończonyUzależnienie od opioidówStany Zjednoczone