Status and phase
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About
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)
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Inclusion and exclusion criteria
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.
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:
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:
Primary purpose
Allocation
Interventional model
Masking
230 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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