OBJECTIVES: To assess the improvement of symptoms and quality of life (QOL) in patients with chronic constipation (CC) treated with prucalopride in China. METHODS: The study was conducted between June 4, 2010 and March 8, 2011 in CC patients at 19 study centers in China. In this multicenter randomized placebo-controlled phase 3 trial, patients with CC either received placebo (n=158) or 2mg of prucalopride (n=155) treatment for 12 weeks. The validated Patient Assessment of Constipation Symptom (PAC-SYM) questionnaire was assessed at specified visits. Data on 12 constipation-related symptoms were obtained from PAC-SYM and summarized into three subscales: stool, abdominal, or rectal symptoms. Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire was used to measure QOL which includes an overall scale and four subscales (physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction). For the overall scale and each subscale of PAC-SYM and PAC-QOL, scores can range from 0 through 4, higher scores indicate worse situation. RESULTS: Both placebo and prucalopride groups were well-matched at baseline in terms of demographic data and disease characteristics such as age, gender distribution, body weight, BMI, overall scales and subscales of PAC-SYM and PAC-QOL. At week 12 last observation carried forward (LOCF), the mean score reduction was significantly greater in the prucalopride group than that in the placebo group for the overall PAC-SYM score (0.3 point), the stool symptom (0.4 point), the abdominal symptom (0.2 point) and the rectal symptom (0.2 point) (P≤0.008). Mean overall PAC-QOL scores showed significant improvement (0.3 point) with prucalopride than with placebo (at week 12 LOCF), as well as physical discomfort (0.3 point), psychosocial discomfort (0.2 point), worries/concerns (0.2 point), and satisfaction (0.6 point) (P≤0.017). CONCLUSIONS: During a treatment period of 12 weeks, prucalopride significantly reduced the severity of symptoms, and improved satisfaction and the disease-related quality of life in Chinese patients with chronic constipation.