Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aim was to evaluate the effect of pharmacological treatments normally used to
      treat functional constipation and in particular PEG, bisacodyl and prucalopride on colonic
      motility as assessed by high-resolution manometry.
    

Detailed description: 
      Rationale: Several treatments with different modes of action are currently available for
      chronic constipation. This study will investigate the effect of these different modes of
      actions of PEG 3350 + electrolytes, bysacodyl and prucalopride and on colonic motility
      parameters (e.g. HAPC).

      Objectives:Primary: to compare and determine the effects of PEG, bisacodyl and prucalopride
      on the number of colonic high amplitude propagated contractions (HAPCs) during a 12-hour
      intraluminal manometry in healthy subjects. Secondary: to evaluate the association between
      motility parameters and number and consistency of bowel movements in healthy subjects.

      Investigational product, dose, and mode of administration: Regimen A: 13.8g polyethylene
      glycol 3350 with sodium bicarbonate, sodium chloride, and potassium chloride, mixed with
      125mL of water administered twice orally as a solution. Regimen B: 10 mg bisacodyl once daily
      oral administration with 125mL of water. Regimen C: 2mg prucalopride, film-coated tablets
      (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water.

      Methodology: This is an open-label, randomized, reader-blinded, 3-period cross-over study
      investigating the effects of PEG 3350 + electrolytes, bisacodyl and prucalopride on colon
      motility with intraluminal manometry. On day 1 of each Treatment Period, a manometry catheter
      will be placed in the colon under conscious sedation and the colonic pressure will be
      continuously measured through 12 hours after administration of each of the investigational
      products (Regimen A, B or C).

      Inclusion criteria: healthy male and non-pregnant, non-breastfeeding female participants,
      aged 18-65 years old at the time of consent. Exclusion criteria: use of medications within 48
      h of dose initiation; structural or metabolic diseases that affect the gastrointestinal
      system and functional gastrointestinal disorders; previous abdominal surgery other than
      appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as
      diabetes, cardiovascular or lung disease; use of agents that influence bowel habit, i.e.
      anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics
      and prokinetics in the 7 days before the study.
    

Intervention name(s): polyethylene glycol; Bisacodyl; Prucalopride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): osmotic laxative; stimulant laxative; prokinetic
Other intervention name(s): macrogol; PEG; Dulcolax; Resolor
Intervention MeSH terms: Prucalopride; Bisacodyl
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: open-label, randomized, reader-blinded, 3-period cross-over study
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: laxatives; constipation