A Single-arm, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy (SLT) for the Reversal of Opioid-induced Constipation (OIC).

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:
• •* Subject and Investigator confirm that the Subject's constipation is induced, or worsened by the Subject's opioid medication (present at Screening)
• •* Subjects with mean BFI score \> 30 at Visit 1
• •* Subjects with \< 3 complete bowel movements (CBMs) in the week preceding the Visit 1, based on Subject's retrospective memory in response to Investigator's question.
• •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 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)).