Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation (OIC)

This study has been terminated.

(The study was stopped by the sponsor based on a non-safety related business priority decision)

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01117051

First received: April 29, 2010

Last updated: June 6, 2014

Last verified: April 2014

History of Changes

Results First Received: April 2, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Investigator); Primary Purpose: Treatment
Conditions:	Non-cancer Pain Opioid Induced Constipation
Interventions:	Drug: placebo Drug: prucalopride

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
Placebo	placebo once daily before breakfast for up to 12 weeks
Prucalopride	1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks

Participant Flow: Overall Study

	Placebo	Prucalopride
STARTED	86	88
COMPLETED	73	77
NOT COMPLETED	13	11
Withdrawal by Subject	5	3
Adverse Event	4	3
Lost to Follow-up	0	1
Did not meet in-/exclusion criteria	0	1
Sponsor's decision	3	1
Surgical procedure	0	1
Randomized by mistake	0	1
Convenience issue	1	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.
Safety Population was used which includes all subjects who were randomized into the study and who had received at least 1 dose of investigational product. 174 subjects were randomized but 5 were not treated (n = 169).

Reporting Groups

	Description
Placebo	placebo once daily before breakfast for up to 12 weeks
Prucalopride	1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
Total	Total of all reporting groups

Baseline Measures

Placebo

Prucalopride

Total

Overall Participants Analyzed
[Units: Participants]

169

Age
[Units: Years]
Mean (Standard Deviation)

57.7 (11.67)

55.7 (12.15)

56.7 (11.92)

Age, Customized
[Units: Participants]

Between >=18 and <65 years

128

Between >=65 and <75 years

>=75 years

Gender
[Units: Participants]

Female

123

Male

Region of Enrollment ^[1]
[Units: Participants]

Belgium

Bulgaria

Czech Republic

Germany

France

United Kingdom

Hungary

Netherlands

Poland

Romania

^[1]	All randomized subjects (n = 174)

Outcome Measures

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1. Primary:

Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week [ Time Frame: 12 weeks ]

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2. Secondary:

Plasma Concentration of Prucalopride at Week 2 [ Time Frame: Week 2 ]

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3. Secondary:

Plasma Concentration of Prucalopride at Week 8 [ Time Frame: Week 8 ]

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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
Due to the early termination of the study, results should be interpreted with caution.

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: Movetis
phone: +1 866 842 5335

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01117051 History of Changes
Other Study ID Numbers:	M0001-C301 SPD555-301 ( Other Identifier: Shire Development LLC ) 2009-015652-20 ( EudraCT Number )
Study First Received:	April 29, 2010
Results First Received:	April 2, 2013
Last Updated:	June 6, 2014

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