A multicenter, randomized study evaluated the safety and tolerability of aqueous solution concentrate (ASC) of polyethylene glycol (PEG) 3350 in patients with functional constipation.

The patients meeting Rome III diagnostic criteria for functional constipation were enrolled and randomized to receive a once-daily dose of PEG 3350 (17 g) ASC or placebo solution for 14 days. The study included- screening period (visit 1), endoscopy procedure (visits 2 and 3), and follow-up via telephonic calls 30 days post-treatment. 

Subjects were assessed for any adverse events (AEs), clinical laboratory evaluations, vital signs, and others. The primary outcome was the proportion of patients with abnormalities of the oral and esophageal mucosa, compared with placebo, while the secondary outcome was to compare the safety and tolerability of ASC by evaluating AEs or adverse drug reactions.

The following observations were made-

• 65 patients were enrolled for the study.
• 31 were randomized to receive PEG 3350 ASC while 34 were randomized to receive placebo.
• 62 patients completed the study. 
• Abnormalities in inflammation of the oral mucosa during visit 2 (before treatment) or visit 3 (after treatment) was seen in none of the patients of either group. 
• PEG 3350 ASC group demonstrated fewer abnormalities of the esophageal mucosa than in the placebo group on visit 3, however, no marked difference in the proportion of abnormalities was seen between the treatment groups. 
• 40 treatment-emergent AEs were marked in 48.4% of patients treated with PEG 3350 ASC
• 41 treatment-emergent AEs were marked in 55.9% of patients treated with placebo.
• No serious AEs or deaths occurred.
• No patient discontinued the therapy due to an AE.

Thus PEG 3350 ASC can be regarded as safe and well tolerable in patients with functional constipation.

Source- Clin Exp Gastroenterol. 2016 Jul 15;9:173-80. doi: 10.2147/CEG.S111693. eCollection 2016.