Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity

Phase 4

Completed

• Conditions: Chronic Constipation
• Interventions: Drug: PEG 3350; Drug: prucalopride

• Registration Number: NCT01707667
• Lead Sponsor: Shire

Brief Summary

To evaluate the different effects of prucalopride and PEG 3350 + electrolytes on colon motor activity in subjects that are chronically constipated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-16
• Study Start: 2013-02-27
• Primary Completion: 2013-11-27
• Study Completion: 2013-11-27
• Results First Submitted: 2014-10-17
• Results First Submitted QC: 2014-10-17
• Results First Posted: 2014-10-22
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Chronic constipation
• Male or female ages 18-75 years
• Non-pregnant, non-lactating female

Exclusion Criteria

• Drug-induced constipation
• Subjects suffering from secondary causes of chronic constipation, such as:
• Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudohypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy.
• Metabolic disorders, e.g. porphyria, uremia, hypokalemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy
• Neurological disorders, e.g. Parkinson's disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyperganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga's disease, or major depression
• Surgery.
• Subjects with insulin-dependent diabetes mellitus
• Rectal evacuation disorder/outlet obstruction
• Subjects with intestinal perforation or obstruction
• Severe renal impairment
• Subjects with a history of alcohol or drug abuse
• Subjects with lactose intolerance
• Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological or psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PEG 3350	PEG 3350	-
Prucalopride	prucalopride	-

Primary Outcome Measures

Name	Time	Method
The Number of High-Amplitude Propagating Contractions (HAPC)	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).

Secondary Outcome Measures

Name	Time	Method
The Mean Amplitude of HAPC	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	over 12 hours post-dose	The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.
Motility Index	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.
Propagation Velocity of HAPC	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	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.
Area Under the Concentration Curve (AUC) of All HAPCs	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.

Trial Locations

Locations (3)

UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg; 🇧🇪 Leuven, Belgium

Oklahoma Foundation for Digestive Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Barts Health NHS Trust; 🇬🇧 Whitechapel, London, United Kingdom