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

Chronic Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707667
• Other study ID #: SPD555-403
• Secondary ID: 2012-002495-13
• Status: Completed
• Phase: Phase 4
• Start date: February 27, 2013
• Est. completion date: November 27, 2013

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 27, 2013
• Est. primary completion date: November 27, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• prucalopride
One 2 mg tablet orally administered on Day 1
• 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).

Locations

Country	Name	City	State
Belgium	UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg	Leuven
United Kingdom	Barts Health NHS Trust	Whitechapel	London
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	over 12 hours post-dose
Secondary	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.	over 12 hours post-dose
Secondary	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.	over 12 hours post-dose
Secondary	Time to First HAPC	The median (95% CI) time to first HAPC after administration of investigational product with amplitude =100mmHg and extension =20cm.	over 12 hours post-dose
Secondary	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.	over 12 hours post-dose
Secondary	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.	over 12 hours post-dose
Secondary	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.	over 12 hours post-dose