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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707667
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: prucalopride Drug: PEG 3350 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prucalopride Drug: prucalopride
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

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01707667

United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Leuven, Belgium, 3000
United Kingdom
Barts Health NHS Trust
Whitechapel, London, United Kingdom
Sponsors and Collaborators
Principal Investigator: Jan Tack, Professor University of Leuven, University Hospital, Department of Gastroenterology, Belgium

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Shire Identifier: NCT01707667     History of Changes
Other Study ID Numbers: SPD555-403
2012-002495-13 ( EudraCT Number )
First Posted: October 16, 2012    Key Record Dates
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Polyethylene glycol 3350
Gastrointestinal Agents