PMID- 27486340
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160803
LR  - 20201001
IS  - 1178-7023 (Print)
IS  - 1178-7023 (Electronic)
IS  - 1178-7023 (Linking)
VI  - 9
DP  - 2016
TI  - Safety of polyethylene glycol 3350 solution in chronic constipation: randomized, 
      placebo-controlled trial.
PG  - 173-80
LID - 10.2147/CEG.S111693 [doi]
AB  - PURPOSE: To evaluate the safety and tolerability of aqueous solution concentrate 
      (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation. 
      PATIENTS AND METHODS: The patients who met Rome III diagnostic criteria for 
      functional constipation were randomized in this multicenter, randomized, 
      placebo-controlled, single-blind study to receive once daily dose of PEG 3350 (17 
      g) ASC or placebo solution for 14 days. The study comprised a screening period 
      (visit 1), endoscopy procedure (visits 2 and 3), and followup telephone calls 30 
      days post-treatment. Safety end points included adverse events (AEs), clinical 
      laboratory evaluations, vital signs, and others. The primary end points were the 
      proportion of patients with abnormalities of the oral and esophageal mucosa, 
      detected by visual and endoscopic examination of the oral cavity and esophagus, 
      respectively, compared with placebo. A secondary objective was to compare the 
      safety and tolerability of ASC by evaluating AEs or adverse drug reactions. 
      RESULTS: A total of 65 patients were enrolled in this study, 31 were randomized 
      to PEG 3350 ASC and 34 were randomized to placebo, of which 62 patients completed 
      the study. No patients in either group showed abnormalities in inflammation of 
      the oral mucosa during visit 2 (before treatment) or visit 3 (after treatment). 
      Fewer abnormalities of the esophageal mucosa were observed in the PEG 3350 ASC 
      group than in the placebo group on visit 3, with no significant difference in the 
      proportion of abnormalities between the treatment groups. Overall, 40 
      treatment-emergent AEs were observed in 48.4% of patients treated with PEG 3350 
      ASC, and 41 treatment-emergent AEs were observed in 55.9% of patients treated 
      with placebo - nonsignificant difference of -7.5% (95% CI: -21.3, 6.3) between 
      treatment groups. No serious AEs or deaths were reported, and no patient 
      discontinued because of an AE. CONCLUSION: PEG 3350 ASC is safe and well 
      tolerated in patients with functional constipation (NCT01885104).
FAU - McGraw, Thomas
AU  - McGraw T
AD  - Global Medical Affairs, Merck & Co., Inc., Kenilworth, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01885104
PT  - Journal Article
DEP - 20160715
PL  - New Zealand
TA  - Clin Exp Gastroenterol
JT  - Clinical and experimental gastroenterology
JID - 101532800
PMC - PMC4956069
OTO - NOTNLM
OT  - constipation
OT  - drug tolerance
OT  - laxatives
OT  - polyethylene glycols
OT  - solutions
EDAT- 2016/08/04 06:00
MHDA- 2016/08/04 06:01
PMCR- 2016/07/15
CRDT- 2016/08/04 06:00
PHST- 2016/08/04 06:00 [entrez]
PHST- 2016/08/04 06:00 [pubmed]
PHST- 2016/08/04 06:01 [medline]
PHST- 2016/07/15 00:00 [pmc-release]
AID - ceg-9-173 [pii]
AID - 10.2147/CEG.S111693 [doi]
PST - epublish
SO  - Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. 
      eCollection 2016.