To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
One 2 mg tablet orally administered on Day 1
13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg
Leuven, Belgium
Barts Health NHS Trust
Whitechapel, London, United Kingdom
The Number of High-Amplitude Propagating Contractions (HAPC)
Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).
Time frame: over 12 hours post-dose
Area Under the Concentration Curve (AUC) of All HAPCs
The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.
Time frame: over 12 hours post-dose
The Mean Amplitude of HAPC
The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.
Time frame: over 12 hours post-dose
Time to First HAPC
The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.
Time frame: over 12 hours post-dose
Propagation Velocity of HAPC
Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.
Time frame: over 12 hours post-dose
Duration of HAPC
The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.
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Time frame: over 12 hours post-dose
Motility Index
Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.
Time frame: over 12 hours post-dose