Clinical trial NCT01707667: Study to Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Constipation
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: The Number of High-Amplitude Propagating Contractions (HAPC)
timeFrame: over 12 hours post-dose
Secondary outcomes:
measure: Area Under the Concentration Curve (AUC) of All HAPCs
timeFrame: over 12 hours post-dose
measure: The Mean Amplitude of HAPC
timeFrame: over 12 hours post-dose
measure: Time to First HAPC
timeFrame: over 12 hours post-dose
measure: Propagation Velocity of HAPC
timeFrame: over 12 hours post-dose
measure: Duration of HAPC
timeFrame: over 12 hours post-dose
measure: Motility Index
timeFrame: over 12 hours post-dose
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Leuven
country: Belgium
facility: UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg
city: Whitechapel
country: United Kingdom
facility: Barts Health NHS Trust
state: London
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Miner PB Jr, Camilleri M, Burton D, Achenbach H, Wan H, Dragone J, Mellgard B. Prucalopride induces high-amplitude propagating contractions in the colon of patients with chronic constipation: a randomized study. Neurogastroenterol Motil. 2016 Sep;28(9):1341-8. doi: 10.1111/nmo.12832. Epub 2016 Jun 7.