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Targin for Non-cancer Pain

10 listopada 2017 zaktualizowane przez: Mundipharma (China) Pharmaceutical Co. Ltd

A Randomized, Double-blind, Double-dummy, Parallel-group, Multicenter Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Non-malignant Pain Taking Oxycodone Equivalent of ≥10 mg/Day and ≤50 mg/Day as Oxycodone/Naloxone Prolonged-release (OXN) Compared to Subjects Taking Oxycodone Prolonged-release (OXY) Tablets Alone.

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release tablets (OXY) based on the Bowel Function Index (BFI)

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

230

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Chiny
      • Beijing, Chiny
        • Peking University Third Hospital
      • Beijing, Chiny
        • Peking Union Medical College Hospital
      • Beijing, Chiny
        • Beijing Friendship Hospital
      • Beijing, Chiny
        • Beijing Tiantan Hospital
      • Beijing, Chiny
        • Beijing Union Hospital
      • Bengbu, Chiny
        • the First Affiliated Hospital of Bengbu Medical Collage
      • Changsha, Chiny
        • Xiangya Hospital Central South University
      • Changsha, Chiny
        • The Third Xiangya Hospital of Central South University
      • Changsha, Chiny
        • The thrid Xiangya Hospital of central south university
      • Chengdu, Chiny
        • West China Hospital
      • Chongqing, Chiny
        • Daping Hospital
      • Chongqing, Chiny
        • South West hospital
      • Fuzhou, Chiny
        • Fuzhou General Hospital
      • Guangzhou, Chiny
        • The third affiliated hospital sun yat-sen university
      • Guizhou, Chiny
        • Guizhou Provincial People's Hospital
      • Harbin, Chiny
        • The Second Affiliated Hospital of Harbin Medical University
      • Jinan, Chiny
        • Shandong Provincial Hospital
      • Shanghai, Chiny
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, Chiny
        • Shanghai Changhai Hospital
      • Shanghai, Chiny
        • Zhongshan Hospital Fudan University
      • Shanghai, Chiny
        • Shanghai sixth people's hospital
      • Shantou, Chiny
        • The First Affiliated Hospital of Shantou University Medical College
      • Shenyang, Chiny
        • The General Hospital of Shenyang Military
      • Wuhan, Chiny
        • The Central Hospital of Wuhan
      • Wuhan, Chiny
        • Tongji Hospital
      • Wuhan, Chiny
        • Union Hospital Tongji Medical College
      • Xuzhou, Chiny
        • The Affiliated Hospital of Xuzhou Medical University
      • Zhejiang, Chiny
        • Second Affiliated Hospital of Zhejiang University
    • Guangdong
      • Guangzhou, Guangdong, Chiny
        • Guangzhou First People's Hospital
      • Shan Tou, Guangdong, Chiny
        • Second Affiliated Hospital of Shan Tou University Medical College
    • Hebei
      • Shijiazhuang, Hebei, Chiny
        • Hebei General Hospital

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

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Screening Inclusion criteria:

  • Males or females, 18 years of age or older
  • Clinical diagnosis of musculo-skeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1. Possible etiologies are conditions related to intervertebral disc disease, spondylolisthesis and osteoarthritis; other similar non-malignant diseases are also eligible.
  • Patients with non-malignant pain that require around-the-clock opioid therapy (oxycodone equivalent of ≥10 mg/day and ≤50 mg/day) who are likely to benefit from WHO step III opioid therapy for the duration of the study
  • Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale."
  • Subjects are either taking opioid medication or willing to take opioids to treat their pain
  • Patients who are willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectable, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomized partner
  • Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements are evidenced by providing written informed consent

  • Subjects taking pre-study, non-opioid analgesics, and all other concomitant medications, including those medications for the treatment of depression and are considered necessary for the subject's welfare, and are anticipated to remain stable throughout the double-blind period of the study, and are to be continued under the supervision of the investigator, are eligible.

    • Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.

Criteria for entry to the Double-Blind phase:

  1. Subjects continue to satisfy screening criteria outlined in the protocol
  2. Subject's OXY dose is between 10-50 mg/day
  3. Subjects who rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as≤4 on 0-10 scale with less than or equal to two doses of Morphine Sulfate tablets rescue medication per day for either the last three consecutive days or four of the last seven days

  4. Subjects who have constipation induced, or worsened by their opioid study medication, as shown by:

    1. The subject's medical need for regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations per week when not taking a laxative, respectively and
    2. The subjects' constipation was considered to be induced, worsened or maintained by their current study opioid medication and
    3. BFI value > 30.
  5. Subjects demonstrate compliance with laxative use, and completing appropriate and legible daily diaries
  6. Subjects taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose and regimen throughout the study, and in the investigator's opinion are willing and able to maintain adequate hydration.

Screening Exclusion criteria:

  1. Females who are pregnant (positive β-hCG test) or lactating
  2. Any history of hypersensitivity or with any contraindication to oxycodone, naloxone, bisacodyl, or related products
  3. Subjects currently taking the equivalent of > 50 mg/day Oxycodone PR
  4. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination, that will place the subject at risk upon exposure to the study medication or that could confound the analysis and/or interpretation of the study results
  5. Subjects with evidence of impaired liver/kidney function upon entry into the study defined as aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels >3 times the upper limit of normal; gamma glutamyltranspeptidase (GGT or GGTP) ≥ 5 times the upper limit of normal; total bilirubin level outside of the reference range; and/or creatinine level outside of the reference range or >2 mg/dl, or in the investigator's opinion, liver and/or kidney impairment to the extent that the subject should not participate in this study
  6. Subjects with evidence of significant structural abnormalities of the gastrointestinal tract or any diseases/conditions that affect bowel transit
  7. Subjects who have required treatment for the diagnosis of irritable bowel syndrome (IBS)
  8. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
  9. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week Double-blind Phase that may have affected GI motility or pain
  10. Subjects diagnosed with cancer, not including basal cell carcinoma
  11. Subjects with Rheumatoid Arthritis (RA)
  12. Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine)
  13. Subjects with active alcohol or drug abuse and/or history of opioid abuse
  14. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period)
  15. Subjects presently taking, or who had taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).

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: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Oxycodone/naloxone prolonged release tablets
Dose strength:5/2.5 mg,10/5mg, 20/10mg,PO,q12h.daily dose from 10/5mg to 50/25mg.treatment duration:12 weeks
Lek: Oxycodone/naloxone prolonged release tablets
Aktywny komparator: Oxycodone prolonged release tablets
Dose strength:5mg,10mg, 20mg,PO,q12h.daily dose from 10mg to 50mg.treatment duration:12 weeks
Lek: Oxycodone/naloxone prolonged release tablets

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Bowel function index(BFI) 12 Weeks
Ramy czasowe: 12 weeks
12 weeks

Miary wyników drugorzędnych

Miara wyniku
Ramy czasowe
Modified BPI-SF-Average Pain over the last 24 hours
Ramy czasowe: 12 weeks
12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Mundipharma (China) Pharmaceutical Co. Ltd

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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 (Rzeczywisty)

1 września 2013

Zakończenie podstawowe (Rzeczywisty)

30 marca 2017

Ukończenie studiów (Rzeczywisty)

30 marca 2017

Daty rejestracji na studia

Pierwszy przesłany

5 sierpnia 2013

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 sierpnia 2013

Pierwszy wysłany (Oszacować)

7 sierpnia 2013

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 listopada 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

10 listopada 2017

Ostatnia weryfikacja

1 listopada 2017

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OXN08-CN-302a

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 Non Cancer Pain

Badania kliniczne na Oxycodone/naloxone prolonged release tablets

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