Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
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|ClinicalTrials.gov Identifier: NCT01707667|
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: prucalopride Drug: PEG 3350||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Randomized, Crossover, Reader-blinded Study to Investigate the Effect of Prucalopride and Polyethylene Glycol 3350 on Colon Motility With Intramural Manometry in Subjects With Chronic Constipation|
|Study Start Date :||January 2013|
|Primary Completion Date :||November 2013|
|Study Completion Date :||December 2013|
One 2 mg tablet orally administered on Day 1
Other Name: Resolor (Marketed name in Europe)
|Active Comparator: PEG 3350||
Drug: PEG 3350
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).
Other Name: Movicol
- The Number of High-Amplitude Propagating Contractions (HAPC) [ Time Frame: over 12 hours post-dose ]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).
- Area Under the Concentration Curve (AUC) of All HAPCs [ Time Frame: over 12 hours post-dose ]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.
- The Mean Amplitude of HAPC [ Time Frame: over 12 hours post-dose ]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 to First HAPC [ Time Frame: over 12 hours post-dose ]The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.
- Propagation Velocity of HAPC [ Time Frame: over 12 hours post-dose ]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.
- Duration of HAPC [ Time Frame: over 12 hours post-dose ]The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.
- Motility Index [ Time Frame: over 12 hours post-dose ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707667
|United States, Oklahoma|
|Oklahoma Foundation for Digestive Research|
|Oklahoma City, Oklahoma, United States|
|UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg|
|Leuven, Belgium, 3000|
|Barts Health NHS Trust|
|Whitechapel, London, United Kingdom|
|Principal Investigator:||Jan Tack, Professor||University of Leuven, University Hospital, Department of Gastroenterology, Belgium|