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Completed

NCT Number: NCT01707667

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

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

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Key information

Conditions

Chronic Constipation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prucalopride

Drug

One 2 mg tablet orally administered on Day 1

Other names: Resolor (Marketed name in Europe)

PEG 3350

Drug

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 names: Movicol

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2012
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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