A Phase IV study has demonstrated that Movicol® relieves constipation in patients with irritable bowel syndrome, and is well-tolerated by these patients. This study was conducted at sites in the Czech Republic, France, Germany, Italy, Poland, Sweden and the United Kingdom. All patients involved in the study had been diagnosed with irritable bowel syndrome with associated constipation at least 3 months prior to the study, and all had experienced the onset of symptoms at least 6 months before diagnosis.
The study consisted of a 2-week “run-in” period, during which no Movicol was administered, and laxatives were not allowed. Patients were then randomly assigned to receive Movicol or an identical inactive placebo for the following 4 weeks. On the first 2 days, patients received one sachet in the morning, and one in the evening, but on Day 3 and thereafter patients were allowed to titrate down to one or up to three sachets per day, depending on the consistency of their stool. During the study period patients kept a diary in which they recorded the number of times they spontaneously opened their bowels, the consistency of the stools, and any unwanted side effects of the treatment.
A total of 219 patients were screened, of which 139 were eligible to be randomised; 68 were assigned to treatment with Movicol and 71 were assigned to treatment with placebo.
The main criterion used to assess whether treatment was effective (the “primary efficacy variable”) was the number of times patients receiving Movicol spontaneously opened their bowels, compared with the number of times patients receiving placebo spontaneously opened their bowels, during the 7-day period prior to Visit 4 (on Day 28). In this respect, Movicol was significantly better than placebo, the number of spontaneous bowel movements in the two groups being 4.55 versus 3.09, respectively. This difference was statistically significant (P<0.0001). In addition, during each week of the previous 3 weeks of treatment, patients receiving Movicol had a higher number of spontaneous bowel movements than patients receiving placebo (3.92 versus 2.99 at Week 1, 4.48 versus 2.54 at Week 2 and 4.79 versus 2.69 at Week 3, respectively).
Overall, 38.8% of patients in the Movicol group and 32.9% of patients in the placebo group experienced unwanted side effects following treatment, many of which were considered unrelated to the administration of Movicol® or placebo. Unwanted effects that were believed to be related to treatment were experienced by 16.4% of patients receiving Movicol® and 8.6% of patients receiving placebo. The most commonly reported drug-related side effects were abdominal pain and diarrhoea during treatment with Movicol® (4.5% of patients), and diarrhoea during treatment with placebo (4.3% of patients). No meaningful changes were observed on physical examination. The unwanted effects that were reported by more than 2% of patients in either treatment group are shown in the table below.
Number and percentage of patients reporting unwanted effects that were believed to be related to treatment
|Unwanted Effect||MOVICOL Number||MOVICOL Percentage||Placebo Number||Placebo Percentage|
It is concluded that Movicol is superior to placebo in relieving constipation in patients with irritable bowel syndrome, and is well-tolerated by patients with this condition, raising no safety concerns.