A single-arm study to assess effect and tolerability of SLT on OIC
Research type
Research Study
Full title
A single-arm, open-label, multicentre, non-randomised, study to assess the effect and tolerability of standardised laxative therapy (SLT) for the reversal of opioid-induced constipation (OIC) in subjects suffering from malignant or non-malignant pain that requires around-the-clock opioid therapy.
IRAS ID
132092
Contact name
Sam Ahmedzai
Contact email
Sponsor organisation
Smerud Medical Research UK Limited
Eudract number
2013-000180-81
ISRCTN Number
N/A
Research summary
Some types of pain (especially in cancer patients) are managed clinically by medicines called opioid analgesics. These are often associated with side effects, of which constipation is the most commonly reported by patients (opioid induced constipation or OIC). OIC can greatly affect a patient’s daily functioning and Quality of Life. To treat OIC, patients receiving opioid analgesics are usually prescribed medicines called laxatives, in line with country specific guidelines. Recommended laxatives and clinical guidelines for the treatment of OIC differ from country to country. This study is designed to collect information from patients suffering from OIC and receiving laxatives to treat their OIC. Results from the current study will be used to determine which country specific clinical guidelines and recommended laxatives are effective for the treatment of OIC. To that end, a range of assessments will be made by the study research team and patients’ themselves, including patient bowel function and Quality of Life (QoL) evaluations.
This study will therefore assess the effectiveness of different laxatives that are used in different countries. It is designed to address the complex range of laxatives that may be used for the treatment of OIC . For the UK, the initial laxatives prescribed for the treatment of OIC are Senna and Ducosate Sodium (which are MHRA approved medications available in the UK) and patients will be prescribed these in accordance with the approved prescribing information.
The study is made up of three study periods as follows : screening, treatment and follow-up . In total there are 9 study visits (6 clinic visits and 3 telephone visits). The study is expected to last a total of 42- 52 days. During the treatment period, patients will be given marketed laxatives according to country-specific guidelines. Effectiveness will be assessed by the research study team and the patients’ themselves including the completion of questionnaires and daily diaries.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0248
Date of REC Opinion
20 Sep 2013
REC opinion
Further Information Favourable Opinion