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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01707667
First received: October 12, 2012
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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


Condition Intervention Phase
Chronic Constipation
Drug: prucalopride
Drug: PEG 3350
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • The Number of High-Amplitude Propagating Contractions (HAPC) [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    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:
  • Area Under the Concentration Curve (AUC) of All HAPCs [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    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.

  • The Mean Amplitude of HAPC [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.

  • Propagation Velocity of HAPC [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.

  • Motility Index [ Time Frame: over 12 hours post-dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707667

Locations
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Belgium
UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg
Leuven, Belgium, 3000
United Kingdom
Barts Health NHS Trust
Whitechapel, London, United Kingdom
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Jan Tack, Professor University of Leuven, University Hospital, Department of Gastroenterology, Belgium
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01707667     History of Changes
Other Study ID Numbers: SPD555-403, 2012-002495-13
Study First Received: October 12, 2012
Results First Received: October 17, 2014
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014