Last updated on July 2016

Targin for Non-cancer Pain

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non Cancer Pain
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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
    tudy. 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
    uch 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
    upervision 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:
    Subjects continue to satisfy screening criteria outlined in the protocol
    Subject's OXY dose is between 10-50 mg/day
    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
    Subjects who have constipation induced, or worsened by their opioid study medication,
    as shown by:
    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
    The subjects' constipation was considered to be induced, worsened or maintained
    by their current study opioid medication and
    BFI value > 30.
    Subjects demonstrate compliance with laxative use, and completing appropriate and
    legible daily diaries
    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:
    Females who are pregnant (positive β-hCG test) or lactating
    Any history of hypersensitivity or with any contraindication to oxycodone, naloxone,
    bisacodyl, or related products
    Subjects currently taking the equivalent of > 50 mg/day Oxycodone PR
    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
    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
    Subjects with evidence of significant structural abnormalities of the
    gastrointestinal tract or any diseases/conditions that affect bowel transit
    Subjects who have required treatment for the diagnosis of irritable bowel syndrome
    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
    Surgery within 2 months prior to the start of the Screening Period, or planned
    urgery during the 12-week Double-blind Phase that may have affected GI motility or
    Subjects diagnosed with cancer, not including basal cell carcinoma
    Subjects with Rheumatoid Arthritis (RA)
    Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone
    or buprenorphine)
    Subjects with active alcohol or drug abuse and/or history of opioid abuse
    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)
    Subjects presently taking, or who had taken naloxone or naltrexone within 30 days of
    tudy entry (defined as the start of the Screening Period).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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