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| |  Prucalopride Significantly Improves Symptoms in Chronic Constipation: Presented at UEGW By Judith Moser, MD VIENNA, Austria -- October 22, 2008 -- In patients with severe chronic constipation, the new enterokinetic agent prucalopride increases the rates of bowel movements without a rebound effect, according to a study presented here at the 16th United European Gastroenterology Week (UEGW). "The objective of this phase 3 study was to evaluate the efficacy and safety of a 4-week treatment and a 4-week re-treatment with prucalopride 4 mg compared with placebo," said Lieve Vandeplassche, PhD, Clinical Development, Movetis NV, Turnhout, Belgium, at an oral session on October 22. During the 2 treatment periods, which were separated by a 2-week washout phase, patients received either prucalopride 4 mg or placebo in a randomised, double-blind manner. Patients in the study had history of constipation for at least 6 months with a maximum of 2 spontaneous complete bowel movements (SCBM) per week, as well as hard stools, sensation of incomplete evacuation or straining at least 25% of the time. The primary efficacy parameter was the percentage of patients with 3 or more SCBM per week. Secondary efficacy parameters included the percentage of patients with an increase of at least 1 SCBM per week, the patient's assessment of the efficacy of treatment, and the Patients' Assessment of Constipation-Symptoms (PAC-SYM), a composite score consisting of 12 questions. A total of 510 patients with a mean history of constipation of 23 years were enrolled. "Eighty percent of the patients had previously used laxatives, and 75% reported that their treatment with laxatives was inadequate," Dr. Vandeplassche said. In both treatment periods, the percentage of patients achieving at least 3 SCBM per week was significantly higher in the prucalopride group compared with the placebo group (40% vs 10%; P <= .001). During the wash-out phase, response rates returned to baseline levels. "No rebound effect of prucalopride was seen," Dr. Vandeplassche explained. A similar picture was observed regarding the percentages of patients with an increase of at least 1 SCBM per week during the 2 treatment periods (50%-60% prucalopride vs 20% placebo; P <= .001). In both treatment phases, 40% of patients treated with prucalopride rated the efficacy of their medication as quite a bit effective/extremely effective compared with 15% of the placebo group (P <= .001). According to the PAC-SYM results, symptoms were much more improved in the prucalopride group than in the placebo group in both treatment periods. The most frequent adverse events were headache, nausea, abdominal pain, and diarrhoea. "They occurred more often in the first treatment period and were also more pronounced in the prucalopride arm," Dr. Vandeplassche reported. Adverse events mainly arose on day 1 of treatment. Analysis excluding adverse events on day 1 yielded a similar picture in the 2 treatment periods and also offset the difference between prucalopride and placebo.
[Presentation title: A Two-Period, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Re-Treatment of Prucalopride (Resolor) on Efficacy and Safety in Patients With Chronic Constipation. Abstract OP398]
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