PMID- 20428949
OWN - NLM
STAT- MEDLINE
DCOM- 20101014
LR  - 20220317
IS  - 1573-2568 (Electronic)
IS  - 0163-2116 (Print)
IS  - 0163-2116 (Linking)
VI  - 55
IP  - 10
DP  - 2010 Oct
TI  - Efficacy and safety of prucalopride in patients with chronic noncancer pain 
      suffering from opioid-induced constipation.
PG  - 2912-21
LID - 10.1007/s10620-010-1229-y [doi]
AB  - BACKGROUND: Opioid-induced constipation (OIC) has negative effects on quality of 
      life (QOL). Prucalopride is a new, selective 5-HT(4) agonist and enterokinetic 
      with strong clinical data in chronic constipation. This study investigated the 
      efficacy, safety, and tolerability of prucalopride in patients with noncancer 
      pain and OIC. METHODS: A phase II, double-blind, placebo-controlled study of 196 
      patients randomized to placebo (n = 66), prucalopride 2 mg (n = 66) or 4 mg (n = 
      64), for 4 weeks, was carried out. The primary endpoint was the proportion of 
      patients with increase from baseline of >/= 1 spontaneous complete bowel movement 
      (SCBM)/week. Secondary endpoints [proportion of patients with >/= 3 SCBM/week, 
      weekly frequency of (SC)BM, severity of constipation, and efficacy of treatment], 
      adverse events (AEs), and safety parameters were also monitored. RESULTS: More 
      patients had an increase from baseline of >/= 1 SCBM per week (weeks 1-4) in the 
      prucalopride groups [35.9% (2 mg) and 40.3% (4 mg)] versus placebo (23.4%), 
      reaching statistical significance in week 1. Over weeks 1-4, more patients in the 
      prucalopride groups achieved an average of >/= 3 SBM per week versus placebo (60.7% 
      and 69.0% versus 43.3%), reaching significance at week 1. Prucalopride 4 mg 
      significantly improved patient-rated severity of constipation and effectiveness 
      of treatment versus placebo. Patient Assessment of Constipation-Symptom (PAC-SYM) 
      total scores and Patient Assessment of Constipation-Quality of Life (PAC-QOL) 
      total and satisfaction subscale scores were improved. The most common AEs were 
      abdominal pain and nausea. There were no clinically relevant differences between 
      groups in vital signs, laboratory measures or electrocardiogram parameters. 
      CONCLUSION: In this population with OIC, prucalopride improved bowel function and 
      was safe and well tolerated.
FAU - Sloots, Cornelius E J
AU  - Sloots CE
AD  - Department of Pediatric Surgery, Erasmus Medical Center, Rotterdam, The 
      Netherlands. c.sloots@erasmusmc.nl
FAU - Rykx, An
AU  - Rykx A
FAU - Cools, Marina
AU  - Cools M
FAU - Kerstens, Rene
AU  - Kerstens R
FAU - De Pauw, Martine
AU  - De Pauw M
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100430
PL  - United States
TA  - Dig Dis Sci
JT  - Digestive diseases and sciences
JID - 7902782
RN  - 0 (Analgesics, Opioid)
RN  - 0 (Benzofurans)
RN  - 0 (Laxatives)
RN  - 0 (Serotonin Receptor Agonists)
RN  - 0A09IUW5TP (prucalopride)
SB  - IM
MH  - Abdominal Pain/chemically induced/*drug therapy
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Analgesics, Opioid/administration & dosage/*adverse effects
MH  - Benzofurans/*administration & dosage/adverse effects
MH  - Constipation/chemically induced/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Electrocardiography
MH  - Female
MH  - Humans
MH  - Laxatives/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Placebo Effect
MH  - Serotonin Receptor Agonists/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Vital Signs
MH  - Young Adult
PMC - PMC2943574
EDAT- 2010/04/30 06:00
MHDA- 2010/10/15 06:00
PMCR- 2010/04/30
CRDT- 2010/04/30 06:00
PHST- 2009/11/16 00:00 [received]
PHST- 2010/03/25 00:00 [accepted]
PHST- 2010/04/30 06:00 [entrez]
PHST- 2010/04/30 06:00 [pubmed]
PHST- 2010/10/15 06:00 [medline]
PHST- 2010/04/30 00:00 [pmc-release]
AID - 1229 [pii]
AID - 10.1007/s10620-010-1229-y [doi]
PST - ppublish
SO  - Dig Dis Sci. 2010 Oct;55(10):2912-21. doi: 10.1007/s10620-010-1229-y. Epub 2010 
      Apr 30.