Status and phase
Conditions
Treatments
About
The main purpose of this study is to assess how effective and tolerable the country specific clinical practice guidelines of SLTs are for UK, France and Sweden are.
The main rationale behind this study is that well controlled comparisons of the various laxatives for the treatment of OIC are lacking. There is lack of evidence suggesting which laxative or combination of laxatives is optimal for managing OIC.
Full description
The study comprises of nine study visits and the total duration of the study is up to 42-52 days Potential subjects, aged 18 years and over, with OIC will be screened for entry into the study at Visit 1 Eligible subjects will attend a 7-day Screening Period (Visit 1). This will be followed by a 28-day Treatment Period (visits 2 to 8:), made up of four clinic visits scheduled 7 days apart (visits 5(day 7), 6(day 14), 7(day 21), 8(day 28): days 7 to 28) and two telephone visits (visits 3 and 4) which will take place during the first week of the Treatment Period. There will be a 7-day Follow-up Period with a follow-up phone call to conclude the study (Visit 9).
Study assessment/ evaluation include vital sign measurements, ECG, safety labs, pregnancy test and physical examination assessments, AEs, Investigator and subject questionnaires and subjects daily diaries.
Subjects will continue to take their prescribed pre-study opioid medication throughout the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female subjects at least 18 years
Females less than one year post-menopausal must have a negative pregnancy test prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. (A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly e.g. sterilisation, implants, injectables, combined oral contraceptives, some intrauterine devices ((IUDs), hormonal), sexual abstinence or vasectomised partner).
Documented history of malignant or non-malignant pain that requires around-the-clock opioid therapy (WHO step II/III opioid analgesics).
Subjects treated with WHO step II/III opioid analgesics for at least 2 weeks prior to Screening Visit (Visit 1), who will continue with the opioid(s) over the proposed study period.
Subjects meeting the following criteria for OIC:
Subjects taking at least one laxative on regular basis (i.e. ≥2 intakes per week during the ≥2 weeks prior to screening) for the treatment of OIC.
Subjects must be willing to take SLT.
Subjects taking daily natural dietary fibre supplementation are eligible if they can maintain their diet throughout the study, and in the Investigator's opinion are willing and able to maintain adequate hydration.
Subjects must be willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
In the Investigator's opinion the Subject's concomitant medication dose will remain stable throughout the study Period (here concomitant medications mean all medications besides opioids (standard and rescue opioid treatment)).
Exclusion criteria
Medical Conditions:
Treatments/Medications:
• Subjects presently taking, or who have taken opioid antagonist(e.g. naloxone, naltrexone and methylnaltrexone) or opioid antagonists containing products (e.g. oxycodone/naloxone, buprenorphine/naloxone, pentazocine/naloxone, tilidine/naloxone) < 30 days prior to the start of the Screening Period.
Additional Screening Exclusion Criteria for Subjects Suffering from Non-malignant Pain:
Additional Screening Exclusion Criteria for Subjects Suffering from Malignant Pain:
Primary purpose
Allocation
Interventional model
Masking
117 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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