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

Primary Purpose

Chronic Constipation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
prucalopride
PEG 3350
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oklahoma Foundation for Digestive Research
  • UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg
  • Barts Health NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prucalopride

PEG 3350

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
Time to First HAPC
The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.
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.
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.
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.

Full Information

First Posted
October 12, 2012
Last Updated
June 10, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01707667
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 27, 2013 (Actual)
Primary Completion Date
November 27, 2013 (Actual)
Study Completion Date
November 27, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prucalopride
Arm Type
Experimental
Arm Title
PEG 3350
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
prucalopride
Other Intervention Name(s)
Resolor (Marketed name in Europe)
Intervention Description
One 2 mg tablet orally administered on Day 1
Intervention Type
Drug
Intervention Name(s)
PEG 3350
Other Intervention Name(s)
Movicol
Intervention Description
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).
Primary Outcome Measure Information:
Title
The Number of High-Amplitude Propagating Contractions (HAPC)
Description
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).
Time Frame
over 12 hours post-dose
Secondary Outcome Measure Information:
Title
Area Under the Concentration Curve (AUC) of All HAPCs
Description
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.
Time Frame
over 12 hours post-dose
Title
The Mean Amplitude of HAPC
Description
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 Frame
over 12 hours post-dose
Title
Time to First HAPC
Description
The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.
Time Frame
over 12 hours post-dose
Title
Propagation Velocity of HAPC
Description
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.
Time Frame
over 12 hours post-dose
Title
Duration of HAPC
Description
The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.
Time Frame
over 12 hours post-dose
Title
Motility Index
Description
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.
Time Frame
over 12 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
UNIVERSITY OF LEUVEN, UNVERSITY HOSPITAL, Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Barts Health NHS Trust
City
Whitechapel
State/Province
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27270968
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.
Results Reference
derived

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

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