Multi-centre, double-blind, randomised, placebo-controlled, parallel group study.
Patients will be treated for 28 days, with clinical assessments carried out over 2 visits. Follow-up will be performed via telephone at a specific interval during the study to determine the outcome of unresolved AEs, any new drug-related AEs or any pregnancies. During the run-in period and the treatment phase, patients are prohibited from taking prescription or over the counter (OTC) laxative medication or constipating medications. Prescription and OTC medications not related to constipation are permitted and must be fully documented, but any changes (e.g., dosage, regimen) are to be limited as much as possible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
sealed laminated sachet, 1 - 3 sachets daily for 4 weeks
Gastroenterologie s.r.o.
Hradec Králové, Czechia
EGK.s.r.o, Sanatorium sv. Anny
Prague, Czechia
To evaluate the efficacy and safety of Movicol® versus placebo in the relief of constipation associated with IBS.
Time frame: April 2009
To evaluate the effect of treatment on other symptoms of IBS.
Time frame: April 2009
To evaluate the effect of treatment on patient's Quality Of Life (QOL).
Time frame: April 2009
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