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

History of Changes

Results First Received: October 17, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Chronic Constipation
Interventions:	Drug: prucalopride Drug: PEG 3350

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PRU-PEG	A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
PEG-PRU	Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.

Participant Flow for 2 periods

Period 1: Period 1

	PRU-PEG	PEG-PRU
STARTED	7	6
COMPLETED	6	6
NOT COMPLETED	1	0
expulsion of colonic sensor catheter	1	0

Period 2: Period 2

	PRU-PEG	PEG-PRU
STARTED	6	6
COMPLETED	6	6
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Safety Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product.

Reporting Groups

	Description
PRU-PEG	A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
PEG-PRU	Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
Total	Total of all reporting groups

Baseline Measures

	PRU-PEG	PEG-PRU	Total
Overall Participants Analyzed [Units: Participants]	7	6	13

Age [Units: Years] Mean (Standard Deviation)	40.3 (11.04)	35.2 (13.18)	37.9 (11.85)

Age, Customized [Units: Participants]
18 - 64	7	6	13

Gender [Units: Participants]
Female	7	6	13
Male	0	0	0

Region of Enrollment [Units: Participants]
UNITED STATES	7	6	13

Outcome Measures

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1. Primary:

The Number of High-Amplitude Propagating Contractions (HAPC) [ Time Frame: over 12 hours post-dose ]

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2. Secondary:

Area Under the Concentration Curve (AUC) of All HAPCs [ Time Frame: over 12 hours post-dose ]

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3. Secondary:

The Mean Amplitude of HAPC [ Time Frame: over 12 hours post-dose ]

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4. Secondary:

Time to First HAPC [ Time Frame: over 12 hours post-dose ]

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5. Secondary:

Propagation Velocity of HAPC [ Time Frame: over 12 hours post-dose ]

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6. Secondary:

Duration of HAPC [ Time Frame: over 12 hours post-dose ]

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7. Secondary:

Motility Index [ Time Frame: over 12 hours post-dose ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

Results Point of Contact:

Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01707667 History of Changes
Other Study ID Numbers:	SPD555-403 2012-002495-13 ( EudraCT Number )
Study First Received:	October 12, 2012
Results First Received:	October 17, 2014
Last Updated:	October 17, 2014

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